- Takeda Pharmaceuticals (Cambridge, MA)
- …Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling , coordinates the process ... patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead...Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory… more
- Integra LifeSciences (Princeton, NJ)
- …new treatment pathways to advance patient outcomes and set new standards of care. The Director , Global Regulatory Labeling is responsible for overseeing ... affairs and quality assurance and working knowledge of global regulatory labeling requirements in key markets/geographies. + Ability to multi-task… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently ... provides strategic and operational leadership on product labeling in collaboration with Global ...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling… more
- AbbVie (Florham Park, NJ)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for setting ... US/EU labeling documents) at Senior level meetings ( Global Regulatory Forum (GRF), Executive Labeling...+ Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience:… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will ... is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global...global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions, and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory guidance to ... assure timelines and milestones. + With support of Commercial RA , develops initial product labeling and assesses...and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary… 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 ... at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Amgen (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** **Live** **What ... Affairs Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory … 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
- AbbVie (Irvine, CA)
- …you will be added to our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, ... North Chicago, IL offices. + Responsible for leading the Global Regulatory Product Team (GRPT), developing, and...ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling … more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... regulatory metrics/information. **WHAT YOU'LL DO** + Develop global regulatory strategies for product development and...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Florida Crystals Corporation (Boca Raton, FL)
- …R egulatory Affairs Specialist reports directly to the Director of Global Regulatory Affairs . This position is responsible for assisting with matters ... regulatory compliance for new and existing product labeling and registration from a global perspective...path activities + Support the Director of Global Regulatory Affairs by providing… 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 ... compliance to global food regulatory standards for the Americas...including but, not limited to auditing and monitoring, and regulatory approval processes. The Director will proactively… more
- Merck (North Wales, PA)
- …regulations, corporate standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure ... **Job Description** Reports to the Director /Senior Director in the Office of...divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions… more
- System One (Florham Park, NJ)
- Senior Manager, Regulatory Affairs (BRANDED PRODUCTS) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview The ... Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL),...meetings related to QOL initiatives. + Support coordination with global regulatory counterparts to ensure alignment of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling ...report(s) and contribute to the performance management for other RA team members + Influences the development of regulations… more
- BeiGene (San Mateo, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory ... expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of changes on business and… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of changes on business and… more