- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- 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
- Fresenius Medical Center (Waltham, MA)
- …of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory ... advocate for regulatory positions, influence decisions, and expedite approvals. + Regulatory Risk Management & Compliance : + Identify and manage … more
- Sumitomo Pharma (Boston, MA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- Merck (Boston, MA)
- …and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and ... Skills:** Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical … more
- Chiesi (Boston, MA)
- …reviewers/approvers to get content approved to support business needs + Ensures regulatory compliance while effectively managing business risks + Understands ... and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing...guidance documents and initiating changes in systems to ensure regulatory compliance . Knowledge of Common Technical Document… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and NDA/IND commitments + Act as an expert resource for eCTD submissions to FDA , ensuring compliance with internal and health authority standards + Support the ... of operations resources for submission documents + Identify new or revised regulatory policies and initiate activities to support compliance + Participate… 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
- Tecomet (Woburn, MA)
- …and communicate the training initiatives and document control and records to ensure compliance to FDA , Global Regulatory bodies and ISO requirements. ... the organization, maintenance and storage of all documents related to FDA /ISO compliance , DMRs, DHRs, DCNs, and Management Review Records. + Maintains… more
- Hologic (Marlborough, MA)
- …product registrations. + Review labeling, marketing materials, and user manuals for compliance with US and international regulatory requirements. + Identify and ... storage systems). + Knowledge of ISO 13485, ISO 9001, FDA , and foreign (EU, Canada, etc.) regulatory ...global teams. + Proactive approach to identifying and resolving compliance issues. + Commitment to continuous learning and professional… more