- 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** Are ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical … more
- Medtronic (Boston, MA)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist is responsible for planning and executing global ... assigned product family. This role partners with the international regulatory affairs group to support global submissions...understanding of FDA and MDR requirements. + Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13483)… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you...Advisor and function as the "R" in the core Medical , Legal, and Regulatory review functions within… more
- Rhythm Pharmaceuticals (Boston, MA)
- …our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the ... your assigned programs. By joining our growing and dynamic regulatory affairs team, you'll be responsible for...programs for products to treat rare diseases and/or unmet medical needs (eg, orphan products, fast track, breakthrough therapies,… more
- Cardinal Health (Mansfield, MA)
- **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to ... enable pharmaceutical, medical and biotechnology companies to obtain regulatory ...as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implement … more
- Sumitomo Pharma (Boston, MA)
- …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...urgency and perseverance to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...Regulatory Affairs (GRA) team based in the US. He/she will...to electronic regulatory submissions and working with regulatory templates + Advanced understanding of medical … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Bausch + Lomb (Boston, MA)
- …with ongoing regulatory training related to products. + Works closely with the Regulatory Affairs labeling group in order to assess and determine the impact ... preferred or equivalent + Minimum of 6 years in Regulatory Affairs or relevant experience in a...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… more
- Bausch + Lomb (Boston, MA)
- …Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics or ... and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… more