- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape. + Understanding of other relevant regional … more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs -...maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates significant autonomy… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- GRAIL (Boston, MA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the ... Preferred **Knowledge and skills** + Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required + Solid… more
- Evident Scientific (Needham, MA)
- …supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, the ... Sr. Mgr., Regulatory Affairs (RA) & Clinical ...clinical evidence synthesis. + Ensure alignment between clinical data, labeling , and regulatory claims. **Post-Market Compliance &… more
- Candela Corporation (Marlborough, MA)
- …improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively ... **Sr. Director , Design and Supplier Quality** Requisition Number **2882**...Computer System/Software (non-product) Validation (CSV), Periodic/Ad-hoc risk reviews, Sterilization, Labeling , and Design Transfer. You also play a significant… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** :Medical Director Pharmacovigilance, Rare Disease & PDT **POSITION DESCRIPTION** : Takeda… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety… more