- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Bausch Health (Bridgewater, NJ)
- …mission of improving people's lives with our health care products. he Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, ... approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. **KEY… more
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... development of Office of Prescription Drug Promotion or Advertising, Promotion, and Labeling Branch advisory submissions and sub part e/h submissions. + Ensure full… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning ... to Commercial teams during the development, review and approval of product labeling and advertising materials. + Work directly with Commercial teams from concept… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications.… more
- Bristol Myers Squibb (Madison, NJ)
- …with limited or no oversight. + Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing ... safety profile, with limited or no oversight. **Department Activities** + Participates in improvement projects. Assist the Patient Safety Scientist team Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS. +… more
- Sanofi Group (Bridgewater, NJ)
- …of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of ... products + Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team members have the information necessary to… more
- Sanofi Group (Bridgewater, NJ)
- …of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of ... products + Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team members have the information necessary to… more