Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals IncManager, Regulatory Affairs, Advertising & PromotionNY$128,600–$210,000 / 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 guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
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.
Regulatory Affairs Senior Manager, Globalization Becton Dickinson and CoRegulatory Affairs Senior Manager, GlobalizationFranklin Lakes, NJ$172,000–$275,200 / yearKnowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of assigned 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 thorough regulatory assessments demonstrating the ability to solve difficult problems.
Senior Manager, Regulatory Affairs Quidelortho CorpSenior Manager, Regulatory AffairsNJRemoteThis position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL The Responsibilities Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
Senior Manager, Regulatory Affairs CMC Spyre Therapeutics IncSenior Manager, Regulatory Affairs CMCNY$150,000–$176,000 / yearWe also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Role Summary: As the Senior Manager, Regulatory Affairs CMC), you will operate as the Regulatory CMC lead for multiple programs, owning strategy and execution from early development through clinical milestones.
Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedRegulatory Affairs ManagerNew York, NY$43–$55 / hourSummary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Manager, Regulatory Affairs Strategy - Immunology & Inflammation Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - Immunology & InflammationTARRYTOWN, NY$128,600–$210,000 / yearp>A typical day might include the following: Coordinate 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: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Senior Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs ManagerNew York, NY$90–$130 / hourThe Senior Regulatory Affairs Manager ensures regulatory compliance of The client / LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Senior Regulatory Affairs Program Manager ImmunityBio IncSenior Regulatory Affairs Program ManagerSummit, NJLead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes. ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
Analyst, Regulatory Affairs Oscar Health IncAnalyst, Regulatory AffairsNY$31.45–$41.28 / hourYou will support the Regulatory Affairs Evidence of Coverage team by serving as a resource on Oscar processes and identify risks to escalate in partnership with their manager. Responsibilities: Support annual QHP filings by ensuring the quality and timeliness of annual filing inputs through initial submission and regulator facing negotiation periods.
Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory Affairs Ernst & Young Global LtdRisk Consulting - Enterprise Risk - Sr Manager - Life Sciences - Regulatory AffairsNew York, NY$138,100–$315,600 / yearIf you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at ssc.customersupport@ey.com. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally: Quality Management Systems.
Analyst, Regulatory Affairs Oscar HealthAnalyst, Regulatory AffairsNew York, NY$31.45–$41.28 / hourp>Artificial Intelligence (AI): Our AI Guidelines outline the acceptable use of artificial intelligence for candidates and detail how we use AI to support our recruiting efforts. California Residents: For information about our collection, use, and disclosure of applicants' personal information as well as applicants' rights over their personal information, please see our Privacy Policy.
Manager/Senior Manager, Regulatory Affairs Operations Axsome Therapeutics IncManager/Senior Manager, Regulatory Affairs OperationsNew York, NYRemote$120,000–$150,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members.
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.
Regulatory Affairs Specialist, Digitalization Becton Dickinson and CoRegulatory Affairs Specialist, DigitalizationFranklin Lakes, NJ$110,200–$176,400 / 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.
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.
Manager, Regulatory Policy & Intelligence Insmed IncManager, Regulatory Policy & IntelligenceNJRemote$133,000–$173,000 / yearReporting to the Senior Director, Regulatory Affairs Strategist, you will serve as a critical resource for global regulatory intelligence - monitoring the evolving regulatory landscape, managing complex policy projects, and ensuring key stakeholders across Insmed are equipped with the regulatory insights needed to make sound, strategic decisions. 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.
Legal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of China Limited, New York BranchLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearFull timeOversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. The VP establishes and maintains RAO policies/procedures and oversees all Regulatory Affairs Matters, including project management, stakeholder relationships, and day-to-day processes, communication with regulators, tracking and coordinating regulatory deliverables, driving the submission process to ensure timely execution and quality assurance, and reporting regulatory updates to Bank Management and committees.
NewLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of ChinaLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearli>Oversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. The VP establishes and maintains RAO policies/procedures and oversees all Regulatory Affairs Matters, including project management, stakeholder relationships, and day-to-day processes, communication with regulators, tracking and coordinating regulatory deliverables, driving the submission process to ensure timely execution and quality assurance, and reporting regulatory updates to Bank Management and committees.
Instrument Company Liaison Strategic Manager, Medical Affairs Becton Dickinson and CoInstrument Company Liaison Strategic Manager, Medical AffairsFranklin Lakes, NJ$168,600–$269,800 / yearThe Instrument Company Liaison (ICL) Strategic Manager, Medical Affairs for Specimen Management (SM), represents MA function in the cross-functional Instrument Company Liaison Team, which is responsible for developing and executing BD SM strategy for major and different instrument companies' collaboration. The ICL Strategic Manager demonstrates understanding of technical/scientific principles applicable to in-vitro diagnostics and those of associated disciplines (such as R&D, Regulatory Affairs, Quality Assurance, or Project Management).
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.
NewManager, Regulatory Quality, Vaccines Pfizer IncManager, Regulatory Quality, VaccinesNew York, NY$88,500–$147,500 / yearYou will operate in a highly cross-functional environment, partnering closely with stakeholders across Research & Development and Vaccines, to ensure regulatory deliverables are completed on time, in compliance with current regulatory guidance, and in a full, submission-ready format. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.
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.
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion Syndax Pharmaceuticals IncDirector, Commercial Regulatory Affairs, Labeling, Advertising, and PromotionNYRemote$225,000–$250,000 / yearli>Conducts precedent searches, analyzes relevant analogs or competitor labeling, labeling guidance and trends; and develops labeling language for inclusion to assigned product labels (TLP, CCDS, USPI, when applicable EU SmPC,) to ensure consistency with the overall product strategy, product claims and information in the CCDS. Leads Labeling cross-functional working group (LWG) and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives by providing expertise in labeling best practices.
Regulatory Manager - Cardiology Columbia UniversityRegulatory Manager - CardiologyNew York, NY$71,400–$73,000 / yearAbility to work with a variety of individuals and groups in a constructive and respectful manner while appreciating the unique contributions of an inclusive workforce that brings together the talents of people across multiple identities. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsNEW YORK, NY$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Manager, Regulatory Lifecycle Maintenance ImmunityBio IncManager, Regulatory Lifecycle MaintenanceSummit, NJp>ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Associate Director, Regulatory Affairs Nuvation Bio, Inc.Associate Director, Regulatory AffairsRemote - Any State US, NYRemote$190,000–$200,000 / yearWe are looking for an experienced hands-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions for Nuvation products. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Associate Director/Director, Regulatory Affairs Axsome TherapeuticsAssociate Director/Director, Regulatory AffairsNew York City, NYRemote$160,000–$215,000 / yearFor more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States.
Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Regeneron Pharmaceuticals IncAssociate Director, CMC Regulatory Affairs (Hematology/Oncology)NYRemote$157,200–$256,600 / yearPerform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents; • Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks. • Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Legal Engineering Manager, In-House (Litigation/Regulatory) HarveyLegal Engineering Manager, In-House (Litigation/Regulatory)New York, New YorkIn addition to managing and developing the team, you will work directly with strategic customers, help shape Harvey’s go-to-market approach, and partner cross-functionally with Product, Marketing, Enablement, and Engineering to improve how Harvey serves the legal industry. Qualified lawyer with 7+ PQE, including significant experience practicing litigation, regulatory, investigations, compliance, white-collar defense, enforcement, employment litigation, financial regulatory matters, government investigations, or other contentious legal work, including experience working in-house.
Legal Engineering Manager, In-House (Litigation/Regulatory) Counsel AI CorpLegal Engineering Manager, In-House (Litigation/Regulatory)NY$315,000–$385,000 / yearIn addition to managing and developing the team, you will work directly with strategic customers, help shape Harvey's go-to-market approach, and partner cross-functionally with Product, Marketing, Enablement, and Engineering to improve how Harvey serves the legal industry. Qualified lawyer with 7+ PQE, including significant experience practicing litigation, regulatory, investigations, compliance, white-collar defense, enforcement, employment litigation, financial regulatory matters, government investigations, or other contentious legal work, including experience working in-house.
NewDirector, Regulatory Affairs Strategy - Genetics Medicine Regeneron Pharmaceuticals IncDirector, Regulatory Affairs Strategy - Genetics MedicineNY$205,000–$341,600 / yearThe Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.
Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSL Behring LLCSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesSummit, NJ$154,000–$182,000 / yearThe Senior Manager, Regional Regulatory Lead (RRL), North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Regulatory Affairs Strategist, Project Management Becton Dickinson and CoRegulatory Affairs Strategist, Project ManagementFranklin Lakes, NJ$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Project Management, is responsible for acting as a subject matter expert and project manager for various high-profile initiatives and business critical projects within BD Regulatory Affairs that may influence across multiple functions. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
NewSenior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines SeqirusSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesSummit, NJ$154,000–$182,000 / yearp>The role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Senior Director, Regulatory Affairs Strategy Immunovant IncSenior Director, Regulatory Affairs StrategyNew York, NY$270,000–$290,000 / yearThe Senior Director will provide deep regulatory expertise, lead health authority interactions, mentor regulatory leaders, and partner closely with cross-functional and Regulatory leadership to ensure consistent, high-quality regulatory strategies that support corporate objectives. Provide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), including coaching, mentoring, and development of future regulatory leaders.
Director, Regulatory Affairs Nektar TherapeuticsDirector, Regulatory AffairsNY$240,000–$275,000 / yearThis role oversees end-to-end planning and delivery of global clinical submissions, leads the creation and release of core regulatory dossiers, drives country-level customization strategies, and ensures high-quality responses to regulatory RFIs to support timely trial startup and advancement. Nektar currently anticipates the base salary for the Senior Specialist, Clinical Regulatory Affairs to range from $240,000 to $275,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience.
Senior Director, Clinical Regulatory Affairs Umoja BioPharma IncSenior Director, Clinical Regulatory AffairsNY$253,000–$312,500 / yearThis role will develop and implement regulatory strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and other unmet medical needs. • Provide regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement.
Associate Director, CMC Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, CMC Regulatory AffairsNYRemote$176,400–$228,250 / yearPowered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need.
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.
Scientific - Global Regulatory CMC Manager TechDigital CorporationScientific - Global Regulatory CMC ManagerSummit, NJ2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
Medical Director, Clinical Regulatory Affairs Oscar Health IncMedical Director, Clinical Regulatory AffairsNew York, NYRemote$264,000–$346,000 / yearWork Location: You must reside in one of the following states: Arizona, California, Colorado, Connecticut, D.C., Florida, Georgia, Illinois, Iowa, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York City, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, or Utah. You will advise senior leadership and work closely with teams across the organization to ensure clinical operations align with policy and regulatory intent.
Regulatory Relations Manager BBVARegulatory Relations ManagerNY$130,000–$145,000 / yearHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information (41 C.F.R. BBVA is seeking a Supervisory Relations Manager to join its Corporate & Investment Banking (CIB) platform in New York, supporting the management of regulatory relationships and supervisory activities across BBVA's U.S. legal entities.
Senior Manager, Regulatory Writing Cytokinetics IncSenior Manager, Regulatory WritingNYRemote$173,700–$202,650 / yearThe Senior Manager, Regulatory Writing is responsible for authoring regulatory documents, including but not limited to clinical study protocols, protocol amendments, clinical study reports (CSRs), clinical summaries, investigators brochures (IBs), pediatric documents, and regulatory authority briefing materials and responses. If a lead writer for assigned programs, serves as the primary point of contact for submission and project teams while acting as the lead author for complex documents while supporting document timelines and content strategy.
Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu LtdDigital Assets Regulatory Management ManagerNY$144,600–$265,100 / yearp>Candidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. Information for applicants with a need for accommodation: https://www2.deloitte.com/us/en/pages/careers/articles/join-deloitte-assistance-for-disabled-applicants.html.
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.
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.
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.
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.