Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
Manager, Regulatory Affairs- CMC Daiichi Sankyo, Inc.Manager, Regulatory Affairs- CMCBasking Ridge, NJ$127,280–$190,920 / yearFull timeWith a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for review by higher-level manager.
NewRegulatory Affairs Senior Associate electroCore IncRegulatory Affairs Senior AssociateRockaway, NJThe position provides regulatory strategy input, prepares and maintains submission and technical documentation content, evaluates product and labeling changes, supports post-market and vigilance obligations, and partners cross-functionally to ensure compliant, timely execution of business objectives. • Provide practical regulatory strategy input for new products, product modifications, labeling changes, software/app updates, manufacturing changes, supplier changes, and market expansion activities.
NewExecutive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
NewDirector, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
NewExecutive Director, Oncology R&D, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Oncology R&D, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeClinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL) Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level Study Outputs: For large-studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.
Sr Director of Regulatory Affairs - North America Perrigo Co PlcSr Director of Regulatory Affairs - North AmericaMorristown, NJ$225,000–$275,000 / yearLCM & Regulatory Operations owns regulatory classification governance, post-launch lifecycle activities (non-innovation), and operational processes and systems; this role sets market priorities and delivery expectations. Category Regulatory Affairs owns ideation-to-launch strategy, regulatory pathways, and global dossier expectations; this role provides market input and executes the agreed strategy locally.
Regulatory Affairs Senior Director, Digitalization Becton Dickinson and CoRegulatory Affairs Senior Director, DigitalizationFranklin Lakes, NJ$230,300–$368,500 / yearThe Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President of Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions. Lead Strategic Initiative Development: Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
Regulatory Affairs Senior Director, Project Management Excellence Becton Dickinson and CoRegulatory Affairs Senior Director, Project Management ExcellenceFranklin Lakes, NJ$230,300–$368,500 / yearKnowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
Senior Director, Regulatory Affairs Lupin LtdSenior Director, Regulatory AffairsSomerset, NJThe Senior Director of Regulatory Affairs is responsible for establishing regulatory direction and providing management support for the US development of complex Inhalation products within Lupins complex portfolio, with a robust execution skill set. This role should also have the capability to implement 505b (2) strategies and submissions, a strong communication strategy with the FDA, and additional strong expertise in the Medical Device area, and the ability to understand the PK/PD strategy.
Director/Sr. Director/Executive Director, Clinical Regulatory Affairs SystimmuneDirector/Sr. Director/Executive Director, Clinical Regulatory AffairsPrinceton, New JerseyThe Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure.
Senior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - Hybrid Sun Pharmaceutical Industries LtdSenior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - HybridPrinceton, NJ$188,500–$230,000 / yearResponsibilities: • Provide regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area • Provide solution oriented and innovative advice to meet the Companys objectives and goals • Provide strategic advice for the development of Promotion advisory submissions • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidance • Continuously monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice • Pursues and understands diverse perspectives inside and outside Sun Pharma to provide risk assessment and mitigation strategies • Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Legal and Compliance • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues • Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based • Provide input on process improvement as needed • Engages with colleagues within the department to help support them in their roles and development • Provide direct management to individuals depending on assignment • Proactively seeks opportunities to learn and develop leadership skills. Education & Qualifications: Education Required: Advanced degree (MS, PhD, PharmD, or JD) Minimum of 5-10 years Regulatory promotional review or 8 to 10 years of related pharmaceutical experience (e.g., Medical promotional review) Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s) Strong understanding of FDA regulations (OPDP/CBER) Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns Proven aptitude to analyze and interpret efficacy and safety data Represents Ad/Promo at labeling meetings and provides strategic regulatory guidance Organizational skills and ability to pay attention to details Demonstrated ability to negotiate and influence others to help build team collaboration Excellent verbal, communication, and presentation skills Manage, oversee, and review the work of one or more direct reports Mentors Ad/Promo and cross-functional team members as needed.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationPrinceton, NJ$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Director, US Regulatory Affairs - Advertising and Promotion SanofiDirector, US Regulatory Affairs - Advertising and PromotionMorristown, NJ$178,500–$257,833.33 / yearDirector/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy Insmed IncSenior Director, Regulatory Affairs, Global Regulatory Lead - Development StrategyBridgewater, NJRemote$222,000–$303,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. You will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA.
Senior Director US Regulatory Affairs Haleon PlcSenior Director US Regulatory AffairsNJAs a senior member of the Regulatory Leadership Team, this position sets regulatory direction at the category level, ensures alignment with enterprise objectives, and influences internal and external stakeholders to shape regulatory strategy, policy, and outcomes. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment.
NewDirector, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Executive Director, Regulatory Affairs Merck & Co IncExecutive Director, Regulatory AffairsNJ$255,800–$402,700 / year10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.
Director, Regulatory Affairs Strategy Judge GroupDirector, Regulatory Affairs StrategyWarren, NJ$190,000–$220,000 / yearThis individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes.
Regulatory Affairs Associate Director, Globalization Becton Dickinson and CoRegulatory Affairs Associate Director, GlobalizationFranklin Lakes, NJ$183,800–$294,100 / yearProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make thorough regulatory assessments demonstrating the ability to solve difficult problems and create effective and innovative solutions. Provide centralized regulatory intelligence and governance related to global product registration to interpret and execute on global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.
Associate Director, Global Regulatory Affairs, Advertising & Promotion GenmabAssociate Director, Global Regulatory Affairs, Advertising & PromotionPrinceton, NJFull timeFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonRahway, NJ$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
Director, Regulatory Affairs Tris Pharma IncDirector, Regulatory AffairsMonmouth Junction, NJ$200,000–$245,000 / yearApply Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. This role is well-suited for a regulatory professional who thrives in lean biotech environments, is comfortable working with ambiguity and can seamlessly shift between strategy input and tactical execution.
Associate Director, Regulatory Affairs Advertising & Promotions Tris Pharma IncAssociate Director, Regulatory Affairs Advertising & PromotionsMonmouth Junction, NJ$180,000–$225,000 / yearTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum of 7 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED.
Senior Director, Regulatory Affairs - Development Strategy Insmed IncSenior Director, Regulatory Affairs - Development StrategyNJRemote$222,000–$303,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. This role will provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions, and act as the primary regulatory contact for the US FDA.
Associate Director, Regulatory Affairs Advertising & Promotion Compliance Kyowa Kirin Pharmaceutical Research IncAssociate Director, Regulatory Affairs Advertising & Promotion CompliancePrinceton, NJKyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
Director, Regulatory Affairs Eikon Therapeutics IncDirector, Regulatory AffairsJersey City, NJ$213,000–$232,750 / yearThis role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz Group AGAssociate Director, Regulatory Affairs - Biosimilars (US)Princeton, NJ$145,600–$279,400 / yearp>With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Associate Director Regulatory Affairs Advertising & Promotion Hybrid AbbVie IncAssociate Director Regulatory Affairs Advertising & Promotion HybridFlorham Park, NJThe Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Director, Regulatory Affairs - Infectious Disease Tonix PharmaceuticalsDirector, Regulatory Affairs - Infectious DiseaseNew JerseyTonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Tonix provides a comprehensive compensation and benefits package which includes: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs.
Director, US Advertising and Promotion, Global Regulatory Affairs SanofiDirector, US Advertising and Promotion, Global Regulatory AffairsMorristown, NJ$178,500–$257,833.33 / yearEstablishes and develops key internal relationships with therapeutic product leaders in Commercial organization, R&D and Corporate functions (e.g., Communications, Compliance, Legal) to foster open communication and teamwork. The Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs.
Assoc Director, Regulatory Affairs - Advertising and Promotion Merck & Co IncAssoc Director, Regulatory Affairs - Advertising and PromotionRahway, NJ$129,000–$203,100 / yearRequired Skills: Clinical Trials, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Electronic Common Technical Document (eCTD), FDA Regulations, Negotiation, Pharmaceutical Industry, Promotional Review, Regulatory Compliance, Regulatory Labeling, Regulatory Strategies, Regulatory Submissions, Stakeholder Management, Strategic Thinking, US Regulatory Affairs. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
Associate Director, Regulatory Affairs Advertising and Promotion Recordati SpAAssociate Director, Regulatory Affairs Advertising and PromotionBridgewater, NJ$137,600–$180,000 / yearRecordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. This role is responsible for supporting regulatory review and activities related to advertising / promotion of our marketed pharmaceutical products in 1 or 2 of the following therapeutic areas: oncology, endocrinology, hematology.
Senior Director, Regulatory Affairs Clinical Dynamix, Inc.Senior Director, Regulatory AffairsJersey City, NJThe Senior Director will represent Company in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department.
Director, Regulatory Affairs - Development Strategy Insmed IncDirector, Regulatory Affairs - Development StrategyBridgewater, NJRemote$185,000–$252,500 / yearReporting to the Executive Director, Regulatory Affairs, you'll provide strategic and operational regulatory leadership to support both business development and early-stage drug development programs and be responsible for strategic evaluation of regulatory risks and opportunities for external assets, including assessing likelihood of technical and regulatory success, and contributing to the development and execution of global regulatory strategies for internal pipeline programs. You will work cross-functionally to enable informed investment decisions and efficient advancement of development programs and develop regulatory strategy for selected drug candidates and provide regulatory input to global cross-functional project teams throughout product development and submission activities and will serve as the global or regional regulatory lead on the projects.
Director, Regulatory Affairs - CMC Rocket Pharmaceuticals IncDirector, Regulatory Affairs - CMCCranbury, NJ$204,000–$244,000 / yearThey will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs. Rocket Pharma is seeking a Director, Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls to support the success of our gene therapy programs by serving as the global product leader for CMC regulatory strategy.
Regulatory Affairs Manager Recordati SpARegulatory Affairs ManagerBridgewater, NJ$97,600–$146,400 / yearRecordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear.
Director of Government Affairs and Community CAMCARE HEALTH CORPORATIONDirector of Government Affairs and CommunityCamden, NJThe Director monitors legislative and regulatory developments affecting community health centers and works collaboratively with executive leadership to ensure the organization remains compliant with federal and state regulations while actively advocating for policies that support access to care for underserved populations. The Director of Government Affairs and Community Engagement is responsible for developing and implementing the organization's governmental relations and advocacy strategy to advance the mission of the Federally Qualified Health Center (FQHC).
NewSenior Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsSenior Manager, Regulatory Affairs, Advertising & PromotionWarren, NJ$150,500–$245,500 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Senior Manager Regulatory Affairs US Advertising and Promotion - US Specialty AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - US SpecialtyFlorham Park, NJOversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
NewSenior Manager Regulatory Affairs Global Reg Strategy US & Canada - Immunology AbbVie IncSenior Manager Regulatory Affairs Global Reg Strategy US & Canada - ImmunologyFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Executive Director, Head of Government Affairs Insmed IncExecutive Director, Head of Government AffairsBridgewater, NJ$280,000–$382,500 / yearThis leader will develop and execute a comprehensive government affairs strategy, working cross-functionally with Legal, Compliance, Communications Regulatory Affairs, Medical Affairs, Market Access, and Commercial teams to ensure Insmed''s interests are effectively represented before Congress, the FDA, HHS, and other relevant government agencies. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications.
Regulatory Affairs Senior Manager, Digitalization Becton Dickinson and CoRegulatory Affairs Senior Manager, DigitalizationFranklin Lakes, NJ$172,000–$275,200 / yearJob Summary: The Senior Manager of Regulatory Affairs, Digitalization is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions, specifically the Regulatory Information Management System (RIM and/or RIMSYS). Support Strategic Initiative Development: Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
Principal Scientist, Regulatory Affairs - CMC State of OregonPrincipal Scientist, Regulatory Affairs - CMCJersey City, New JerseyThis role is accountable for developing and executing global Regulatory CMC strategies across assigned products to ensure successful product lifecycle management, including original registrations, post-approval changes, and ongoing regulatory maintenance, in accordance with global regulations, guidance, and Organon procedures. Reporting to the Executive Director, Head of General Medicine Portfolio, Regulatory Chemistry, Manufacturing & Controls (CMC), the Principal Scientist, Team Lead is responsible for providing strategic Regulatory CMC leadership for the Cardiovascular portfolio within the General Medicine organization.
Regulatory Affairs Strategist, Digitalization Becton Dickinson and CoRegulatory Affairs Strategist, DigitalizationFranklin Lakes, NJ$137,500–$220,100 / yearProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Knowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
Executive Director, Medical Affairs Celldex Therapeutics IncExecutive Director, Medical AffairsNJ$233,631–$303,417 / yearAdvanced scientific degree required (MD, PhD, PharmD or equivalent) 10-15+ years of combined clinical and/or biopharma experience, including Medical Affairs leadership in Immunology, Allergy, and/or Dermatology; launch experience strongly preferred Prior people management (direct reports) and matrix leadership across Field Medical (MSLs) and in‑house medical teams Proven track record leading publications/scientific communications programs and compliant data dissemination Exceptional scientific acumen and communication; ability to translate complex data for clinical, regulatory, commercial, and access stakeholders Strength in publication strategy/execution, KOL development, advisory board design, and congress/symposia strategy and execution Omni‑channel mindset with facility applying insights/analytics to optimize medical impact High integrity and strong judgment in a multi‑functional matrix; skilled in prioritization, budgeting, and vendor management Willingness to travel ~25-30% for priority engagements and congresses. Therapeutic area medical affairs strategy and planning Develop Medical Affairs strategies and plans focused on scientific communications and engagements with medical community to build Celldex presence and capabilities in Allergy and Dermatology Lead a team of Medical Affairs specialists to develop a strategically and commercially aligned scientific engagement and communication strategy for key immunology assets in Allergy and Dermatology therapeutic areas Provide disease‑area subject matter expertise on behalf of Medical Affairs to cross-functional partners, including Commercial (Marketing, Value and Access), R&D (clinical development, translational medicine, medical safety) to inform study designs, labels, and postmarketing commitments.