- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance ... our pipeline and drive our strategic priorities.The Director, Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to ... The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global...Rico Registrations Labeling Tools: Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Genmab (Plainsboro, NJ)
- …of US Medical Affairs Hematology Strategy will report to the Director, US Medical Affairs Hematology Strategy Lead . S/he will assist the strategy lead to ... US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborations within and across line functions, eg Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Operations. Formulates strategic ... with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.This position independently… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Affairs (MAPA), Portfolio Strategy, Insights and Analytics, Commercial Excellence, Legal, Regulatory Affairs , and other relevant NNI departments to ensure ... as we embark on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic direction and initiatives within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical ... external agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs , Medical Affairs , Convention Marketing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, Enterprise Insights, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Managers, and Market Access), Brand Marketing, Training, Market Access & Public Affairs , Trade, Legal, Compliance, Finance, HEOR, and Market Research. The position… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs , and external partners, to ensure alignment and ... as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately 50 employees, spanning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Managers, and Market Access), Brand Marketing, Training, Market Access & Public Affairs , Trade, Legal, Compliance, Finance, HEOR, and Market Research. The position… more
- Merck & Co. (Rahway, NJ)
- …our Company, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies ... where relevant, DP) development teams for various assets/biomarkers (including Regulatory , Commercial, Business Development, Project Management, Operations, Clinical Development,… more
- Merck & Co. (Rahway, NJ)
- …of interest.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Formation Bio (New York, NY)
- …preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs , Clinical Operations) to ensure alignment on quality ... and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting… more
- Formation Bio (New York, NY)
- …needed. Collaborate with cross-functional teams (eg, Engineering, Tech, R&D, Manufacturing, Regulatory Affairs ) to ensure alignment on quality objectives, ... excellence, accountability, and continuous learning. Serve as a subject matter expert on quality assurance matters during regulatory inspections, customer… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... drive our strategic priorities. The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for development...by regulatory agencies. + Functions as global regulatory lead assigned to programs where the… more
- Bausch Health (Bridgewater, NJ)
- …drive our collective progress and impact. Responsibilities: + Manages or represents Regulatory Affairs on the US promotional review committees for prescription ... of market promotional and advertising strategies. + Updates the Regulatory Affairs advertising and promotion staff, review... advice, response to FDA action letters, and helps lead the company in discussions with OPDP. + Implements… more
- BlackRock (New York, NY)
- …security, financial technology, and critical infrastructure. This role is for a Director of Regulatory Affairs on the US Government Affairs & Public Policy ... role** BlackRock has a long history as a trusted, expert resource to governments and policymakers around the world...world on financial markets policy. Since 2009, the Government Affairs & Public Policy team has steadily established the… more
- Merck (Rahway, NJ)
- …Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) functional areas, to ensure ... implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements. These agreements include but are not… more
- BlackRock (New York, NY)
- …security, and investment in critical infrastructure. This role is for a Vice President, Regulatory Affairs on the US Government Affairs & Public Policy ... has a long history of service as a trusted, expert resource to governments and policymakers around the world....governments and policymakers around the world. Since the Government Affairs & Public Policy team was created in 2009,… more
