- Oracle (Boston, MA)
- …competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, ... globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a...basis to maintain market authorization. + Support internal and external audits to identify, evaluate, disclose, and appropriately remedy… more
- Beth Israel Lahey Health (Burlington, MA)
- …taking a job, you're making a difference in people's lives.** The Regulatory Affairs Specialist supports the activities of the Regulatory Affairs Department in ... to quality, safety, and compliance initiatives across the organization. The Regulatory Affairs Specialist works under the direction of the Director of Regulatory … more
- Chiesi (Boston, MA)
- …looking for This is what you will do The Global Rare Diseases Medical Affairs Intern will support strategic and operational initiatives within the Medical Affairs ... and cross-functional collaboration, providing a strong foundation for a career in medical affairs . You'll be responsible for: + Assist in the development of medical… more
- Bristol Myers Squibb (Cambridge, MA)
- …. **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, focusing on ... investigational assay development and clinical specimen testing, while overseeing external investigational use only assay development-ensuring strategic alignment with… more
- Sanofi Group (Cambridge, MA)
- …ICER responses, value-based contracting strategies, etc. + Partner with State Government Affairs and external advocacy organizations to shape emerging access and ... payer dossiers, field materials, and digital platforms. + Partner with US Medical Affairs /Value & Access to ensure appropriate use of HEOR evidence in field… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations,… more
- Boston University (Boston, MA)
- **STAFF ACCOUNTANT, GIFTS & ENDOWMENT, Financial Affairs , Comptroller's Office, General Accounting** **Job Description** **STAFF ACCOUNTANT, GIFTS & ENDOWMENT, ... Financial Affairs , Comptroller's Office, General Accounting** **Category** Charles River Campus...manner. + Assist in the preparation of the annual external audit, including preparing schedules and support related to… 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 ready to ... critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional teams… more
- Edwards Lifesciences (Boston, MA)
- …at the heart of everything we do. As a key member of our Medical Affairs team, you will drive the strategic direction of our Transcatheter Heart Valve (THV) evidence ... for senior leadership. + Driving Evidence Planning: Collaborating with internal and external stakeholders to shape and execute a robust evidence generation roadmap… more
- Philips (Cambridge, MA)
- The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety ... + You've acquired a minimum of 7+ years' experience in Regulatory Affairs /Strategy within FDA regulated Medical Device environments. + You have proven expertise… more