- Sanofi Group (Cambridge, MA)
- …relationships with FDA are established and maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Amgen (Cambridge, MA)
- … strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, biosimilars, and ... Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's… more
- Takeda Pharmaceuticals (Boston, MA)
- …the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** :Medical Director Pharmacovigilance, Rare Disease & PDT **POSITION DESCRIPTION** : Takeda ... Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT with the following...Disease & PDT with the following duties: serve as Global Safety Lead (GSL) and the Company-wide patient safety… more
- GRAIL (Boston, MA)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with...to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …well as other labeling documents. + Demonstrate knowledge of local and global health authority requirements. + Support GPSE in the maintenance of a highly ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Evident Scientific (Needham, MA)
- …documentation, labeling , and registration activities. + Contribute to global regulatory strategy discussions, providing US compliance insights. **Leadership ... operations, supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, the… more