NewDirector, Regulatory Affairs, Ex-US Larimar TherapeuticsDirector, Regulatory Affairs, Ex-USPhiladelphia, PAPrepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings. Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
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.
Executive 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.
NewAssociate Director, US Brand Marketing CSL SeqirusAssociate Director, US Brand MarketingSummit, NJ$180,000–$205,000With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
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.
NewDirector, Business Development Larimar TherapeuticsDirector, Business DevelopmentPhiladelphia, PAThe successful candidate will have a deep understanding of business and market dynamics, transactions and partnerships, a track record of developing and executing successful corporate strategies, robust understanding of finance, and the ability to work collaboratively with cross-functional teams. Foster collaborative and supportive cross-functional working relationships, including engaging the senior leadership team in the development and prioritization of long-term strategies and acting as a thought partner with the business to make effective and timely decisions .
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.
Director of Regulatory Affairs Avalo TherapeuticsDirector of Regulatory AffairsPhiladelphia, PAThe Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities. Avalo Therapeutics is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory leadership for abdakibart (AVTX-009), the company's lead asset, as it advances into Phase 3, and potential registration.
NewAccounting Associate Jewish Federation of Greater PhiladelphiaAccounting AssociatePhiladelphia, PAReporting to the the Director of EITC (Educational Improvement Tax Credit) and working closely with the Director, Finance Department, and the Fundraising department's EITC Committee, the Accounting Associate supports core program workflows, regulatory compliance, and data-driven decision-making. The responsibilities include processing donations, producing financial reports, tracking and verifying scholarship allocations, regulatory compliance, supporting program operations, and stakeholder engagement.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
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.
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.
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.
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, 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.
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.
NewDirector, Regulatory Affairs Advertising & Promotion Acadia Pharmaceuticals IncDirector, Regulatory Affairs Advertising & PromotionPrinceton, NJ$193,400–$241,800 / yearThe position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA''s Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia''s product portfolio. We 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.
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 - 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.
NewDirector, Global Regulatory Affairs & Clinical Safety Business Development Merck & Co IncDirector, Global Regulatory Affairs & Clinical Safety Business DevelopmentRahway, NJ$173,200–$272,600 / yearWork with the staff to manage the strategy, negotiation, and provisions of regulatory components of agreements as they relate to product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures. More specifically, this position will oversee staff who will manage the business development stages of strategy, evaluation, due diligence, contracting, implementation support and maintenance of regulatory activities relating to our Company business partner deals.
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.
Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz Group AGAssociate Director, Regulatory Affairs - Biosimilars (US)Princeton, NJ$145,600–$279,400 / yearWith 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.
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.
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.
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.
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.
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.
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.
Director of Academic Affairs and Student Success Temple UniversityDirector of Academic Affairs and Student SuccessPhiladelphia, Pennsylvania$90,000–$100,000University College supports Temple's mission by providing high quality education to its students that is accessible, affordable, diverse, and engaged with the broader community across its campuses at Ambler, Center City, Harrisburg, Main Campus, and online. The Director of Academic Affairs and Student Success provides leadership and operational oversight for academic programming and student success initiatives across the University College and its campuses, with a primary focus on the Bachelor of General Studies.
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).
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.
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.
Regulatory Affairs Specialist, Global Quaker Chemical CorpRegulatory Affairs Specialist, GlobalPASupport chemical regulatory activities related to documentation, including updating raw material information, communicating changes to raw material classifications, data management, and updating the SDS system. Supports the Product Stewardship organization globally with responses to key stakeholders including regulatory inquiries, SDS authoring, and answering regulatory inquiries.
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.
Executive Director, US Medical Affairs, Oncology Solid Tumor Lead Jazz Pharmaceuticals PlcExecutive Director, US Medical Affairs, Oncology Solid Tumor LeadPhiladelphia, PARemote$304,000–$456,000 / yearThis role will be the strategic partner for the Oncology Solid Tumor Commercial Lead and collaborate extensively on the design and execution of deployment of field colleagues in support of the therapeutic space, including the design and execution of account-level cross-functional collaboration, quality engagement, field and payer value, evidence strategy and execution, and serve as an SME in compliant medical design. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
Executive Director - Global Scientific Marketing Affairs, Companion Animal Merck & Co IncExecutive Director - Global Scientific Marketing Affairs, Companion AnimalRahway, NJ$231,900–$365,000 / yearRequired Skills: Budget Management, Business Compliance, Business Expansion, Conflict Resolution, Cross-Cultural Awareness, Customer-Focused, Financial Budgeting, Interpersonal Relationships, Key Opinion Leader Management, Marketing Communications (MarCom), Market Research, Medical Affairs, Pricing Strategies, Product Management, Professional Networking, Public Finance Management, Segmentation Strategy, Strategic Decisions, Transformational Leadership, Veterinary Medicine. The Executive Director - Global Scientific Marketing Affairs, Companion Animal, reports directly to the Associate Vice President of the Companion Animal Business Unit and will lead a core team of technical services directors with a scope of influence extending globally, and who influence extended teams consisting of 10 to 100 commercial and technical services team members across all geographies.
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.
Principal Scientist (Director) - Regulatory Affairs-CMC Merck & Co IncPrincipal Scientist (Director) - Regulatory Affairs-CMCRahway, NJ$190,800–$300,300 / yearThe Principal Scientist / Director responsibilities include but are not limited to: • Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in development or commercial products. Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organizations biologics product franchises in accordance with domestic and international regulations and guidance.
Medical Director, Dermatology- US Medical Affairs Johnson & JohnsonMedical Director, Dermatology- US Medical AffairsPAContribute to US Dermatology Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the Dermatology IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Dermatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Dermatology TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans. Develop and execute Medical Affairs sponsored/supported Phase IIIb/IV trials, registries, real-world evidence, and collaborations by leading study design, protocol development, analysis plan development, and providing overall trial leadership (including execution, monitoring, supervision, compliance, and risk identification/ mitigation).
Regional Government Affairs Director - Northeast ModivCare Inc.Regional Government Affairs Director - NortheastNJ$159,900–$215,900 / yearThe position will design and implement state-level advocacy strategies aligned with enterprise priorities and will manage engagement with key stakeholders and execution of public affairs initiatives as directed and designed in collaboration with Corporate Affairs leadership. Serves as the companys primary representative at the assigned state capitols before executive leadership, including Medicaid directors, transportation program leaders, and personal care services (PCS) administrators.
Associate Director, Regulatory Affairs - CMC PTC Therapeutics IncAssociate Director, Regulatory Affairs - CMCNJ$169,100–$212,800 / yearLeads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements. Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.
Senior Director, US Oncology Medical Affairs, Diagnostics Daiichi Sankyo Co LtdSenior Director, US Oncology Medical Affairs, DiagnosticsBasking Ridge, NJ$230,175–$383,625 / yearMust have oncology experience, specifically in solid tumors Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities Demonstrated ability to lead and influence others internally and externally Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. US Product Team, US Brand Team, Global Medical Team, etc.) Relationships with or proven history developing key external experts Proven ability to manage multiple priorities at one time Strong knowledge of medical strategy, clinical diagnostic development, and Field Medical activities required Knowledge of ADC or other biologics, or small molecules Demonstrated experience working with an alliance partner company preferred.
Senior Director, Medical Affairs, Therapeutic Head & National Field Lead, Ophthalmics, Princeton, NJ Sun Pharmaceutical Industries LtdSenior Director, Medical Affairs, Therapeutic Head & National Field Lead, Ophthalmics, Princeton, NJPrinceton, NJ$243,000–$297,000 / yearDriven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients. This role is responsible for developing and executing medical strategy, while also leading, coaching, and overseeing a team of Medical Science Liaisons (MSLs) to ensure high-quality scientific engagement with external stakeholders.
Medical Director, Dermatology- US Medical Affairs 6120-Janssen Scientific Affairs Legal EntityMedical Director, Dermatology- US Medical AffairsHorsham, PennsylvaniaContribute to US Dermatology Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the Dermatology IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Dermatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Dermatology TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans. Develop and execute Medical Affairs sponsored/supported Phase IIIb/IV trials, registries, real-world evidence, and collaborations by leading study design, protocol development, analysis plan development, and providing overall trial leadership (including execution, monitoring, supervision, compliance, and risk identification/ mitigation).
Senior Medical Director, Global Medical Affairs GI & Hepatology Bausch Health Companies IncSenior Medical Director, Global Medical Affairs GI & HepatologyBridgewater, NJ$247,000–$339,000 / yearThis role provides strategic medical leadership across the product lifecycle and ensures scientific credibility, patient‑centricity, and value generation for key stakeholders including regulators, payers, healthcare professionals, and patients. Work in close partnership with cross-functional teams including Field Medical Excellence, Evidence Generation/HEOR, Medical Operations, Medical Information, International, R&D, Commercial, Market Access, and Regulatory, to ensure medical strategies are fully aligned with enterprise priorities.