- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr Director , Labeling , Policy and Intelligence. The position… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...positive interactions with colleagues. Essential Functions Therapeutic Area: Assist Manager/ Director in review of labeling for marketed… more
- Merck & Co. (North Wales, PA)
- …review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and ... Job DescriptionReports to the Director /Senior Director in the Office of...corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product ... 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. (Bernards, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is Home ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Takeda Pharmaceuticals (Columbus, OH)
- …employment application is true to the best of my knowledge. **Job Description** The Regulatory Affairs - Labeling , Associate Director is responsible for ... the world. **How you will contribute:** + The Associate Director , GRA Labeling Compliance, is responsible for...local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders… 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
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Leader (General ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the General Medicine -… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area.… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and... impact of new campaign concepts, target, or product labeling , and to provide strategic regulatory guidance… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- BeiGene (Emeryville, CA)
- …with applicable regulatory requirements and guidelines, and consistency with approved labeling . **Essential Functions of the job:** + Oversees the regulatory ... the Labeling Working Group. + Serve as the lead regulatory representative on various cross-functional teams, including promotional and medical review committees.… more
- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will...support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for… more
- Sumitomo Pharma (Columbus, OH)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for… more
- The Hershey Company (Hershey, PA)
- …location is Hershey or east coast with travel to Hershey monthly. * Overview* The Director of Regulatory Affairs for the Americas is responsible to assure ... including but, not limited to auditing and monitoring, and regulatory approval processes. The Director will proactively...issues impactful to the business. 3. Lead the cross-functional Regulatory & Scientific Affairs team to continuously… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... process to ensure submission approval. + Review and approve labeling to ensure compliance. + Monitor emerging issues and...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
