- Leica Biosystems (Boston, MA)
- …make an impact.Learn about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for ... Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international ... 3 days per week) based in Marlborough, MA. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and… more
- Danaher Corporation (Boston, MA)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...internal procedures are updated to reflect evolving US and international regulations. + Assess the impacts of relevant drug… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Medtronic (Mansfield, MA)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for ... development and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on … more
- Sanofi Group (Cambridge, MA)
- ** Regulatory Affairs Innovation Lead - VIE Contract** + _Location: USA, Cambridge_ + _Target start date:_ _01/12/2025_ iMove, the Sanofi VIE Program, is ... PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE...+ Minimum 1 year of full-time work experience in regulatory affairs , life sciences consulting, process improvement,… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
- Sumitomo Pharma (Boston, MA)
- …Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving ... seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior … more
