- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... needed. Acts as point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD or ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior… more
- Genmab (Woodbridge, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, the regulatory leader will ... chosen candidate will manage and mentor a group of Regulatory Affairs strategists. As a key member...submissions of IND, (s)NDA/BLA to US FDA Experience with labeling and PMC/PMR negotiations with US FDA Ability to… more
- Genmab (Yardley, PA)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily responsible ... the path to market, as applicable. Collaborate with the Labeling team to develop the Company Core Data Sheet...Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation… more
- Merck & Co. (North Wales, PA)
- …prioritiesCollaborate with key stakeholders across the enterprise including Medical Affairs , Outcomes Research, Global Marketing, Clinical, Regulatory , ... around the world. Join our organization as a results-driven and visionary Director , Product Marketing Owner - Scientific for Atherosclerosis. As a key leader… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development (R&D), Quality ... facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and...Assurance (QA), Pharmacovigilance, Medical Affairs , etc.) on strategic and tactical clinical development issues… more
- Merck & Co. (North Wales, PA)
- …that interface with internal and external stakeholders, including US Medical Affairs , Regional Vaccine Medical Directors, Global Marketing, the Center for ... and advocacy perspective, ensuring alignment with marketing strategy Collaborate with Medical Affairs to develop and execute upon a scientific engagement plan that… more
- Careerbuilder-US (Rahway, NJ)
- …Major activities and responsibilities: . With the support and guidance of the Executive Director of US Regulatory Affairs , the Specialist has the following ... of a team to prepare and submit marketed product reports to the regulatory authorities; maintains US state registrations, labeling , drug listings; the… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for...will be overall responsible for ensuring compliance with US regulatory requirements for labeling , and for coordinating… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's ... organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- AbbVie (North Chicago, IL)
- …submissions, renewals and competitive analysis. + Presents process, strategy and product labeling at Senior level meetings including Regulatory Strategy Review ... (RSR), Regulatory Strategy Team (RST), Global Regulatory Product Team (GRPT), Labeling Review and...third party agreements, all under the direction of the Director , Strategic Global Labeling . Leveling of the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …consistency with product labeling and with all applicable regulations. TheSenior Director , Commercial Regulatory Affairs will stay abreast of changes ... on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development… more
- Amgen (Los Angeles, CA)
- …science that can turn the tide of serious, life-interrupting illnesses. **Executive Director of Regulatory Affairs ** **Live** **What you will ... change the world. In this vital role as Executive Director of Regulatory Affairs , you...development, global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions +… more
- Bausch Health (Bridgewater, NJ)
- … regulatory considerations that may impact business. + Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert ... and regulatory agency guidance. Responsibilities: + Manages or represents Regulatory Affairs on the promotional review committees for prescription products… more
- Teva Pharmaceuticals (West Chester, PA)
- …development, analytical methods, formulation development, manufacturing, and labeling . The Sr Director , Regulatory Affairs CMC is also responsible for ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...development, global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions +… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Detail-oriented with… more
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