- 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
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Labeling cross functional teams including clinical, safety, medical affairs , and commercial, to ensure the highest level of… 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