- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related ... RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and… 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
- Actalent (Parsippany Troy Hills, NJ)
- Job Description: + Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical ... documents. + Assist and support the review of packaging, labeling , storage, logistics, and distribution documentation of the investigational product.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …working within established timelines of investigational product manufacturing, labeling , release, distribution and return/destruction, and/or helping to establish ... of RFP, assumptions and SOW for CROs and IP services vendors ( labeling , packaging, distribution; IVRS/IWRS) + Provides input, reviews, and approves vendor study… more
