- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject… more
- Sumitomo Pharma (Boston, MA)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- BeOne Medicines (Cambridge, MA)
- …clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. + Liaises and negotiates with FDA as needed ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director, Regulatory Affairs in Cambridge, MA, USA: **Job Duties:**...and risk assessments, critical issue management and advice on FDA Health Authority interactions. + Uses extensive knowledge of… more
- Eliassen Group (Marlborough, MA)
- …and define designs. . Ensure all design and development activities adhere to regulatory requirements (eg, FDA , CE, MDR), and maintain detailed, accurate ... to support medical device product development in alignment with regulatory requirements and industry standards. . Collaborate with cross-functional teams,… more
- United Therapeutics (Boston, MA)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory ... across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the preparation and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience is responsible for developing innovative global ... regulatory strategies and providing strategic regulatory guidance...The Sr Director/Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Canon USA & Affiliates (Boston, MA)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... of reportable events + Provide information as requested for the filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more