- 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
- 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)
- …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. (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. (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
- 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... 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
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia...approve labeling to ensure compliance. + Represent regulatory affairs in product recall and recall… 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
- 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
- ThermoFisher Scientific (Cambridge, MA)
- …opportunities to make significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs (RA) is responsible for owning ... Director is able to combine knowledge of scientific, regulatory and business issues to enable products that are...global Q&RA system efficiencies to meet customer and global regulatory standards + Reviews and approves proposed labeling… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling , coordinates the ... EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape. + Understanding of other relevant regional … more
- BeiGene (Emeryville, CA)
- …met while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the solid tumor ... The Executive Director , Solid Tumor North America Lead will be...labeling changes. + Maintains awareness of the US regulatory environment and assesses impact of changes on business… more
- AbbVie (Irvine, CA)
- …you will be added to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global ... and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary regulatory interface… more
- Integra LifeSciences (Princeton, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The Director , Global Regulatory Labeling is responsible for overseeing the ... **QUALIFICATIONS** + Bachelor's degree and 7+ years of experience in regulatory affairs , quality assurance and/or labeling including direct experience with… more
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