- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- Olympus Corporation of the Americas (Westborough, MA)
- …technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning considerations ... + Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device ... Device . + Demonstrated leadership in managing the global submission process for regulatory approvals across… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. + Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 years ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports … more
- Olympus Corporation of the Americas (Westborough, MA)
- …BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. + Minimum ... of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… 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 ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the… more
- Sanofi Group (Framingham, MA)
- …we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves ... **Job Title:** Global Regulatory Affairs CMC...**Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham,...GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory… more
- Sanofi Group (Framingham, MA)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting ... pathways. The team is accountable for developing and implementing global regulatory strategies for device ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Sanofi Group (Cambridge, MA)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting ... pathways. The team is accountable for developing and implementing global regulatory strategies for device ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Takeda Pharmaceuticals (Boston, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products… more
- Dentsply Sirona (Waltham, MA)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA....+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited… more
- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a ... (peer-to-peer) as well as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and… more
- Philips (Cambridge, MA)
- …+ You've acquired a minimum of 7+ years' experience in Regulatory Affairs /Strategy within FDA regulated Medical Device environments. + You have proven ... The Principal Regulatory Affairs Specialist will develop and...projects across a spectrum of product lines. + Monitor global regulatory landscapes and guide cross-functional teams… more
- Sanofi Group (Cambridge, MA)
- …other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically within advertising ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs (GMA) based in Cambridge,… more
- Bausch + Lomb (Boston, MA)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work...Affairs . This position does not work with medical device , cosmetics or supplements and we will only be… more
- ThermoFisher Scientific (Waltham, MA)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... Day in the Life:** + Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical… more
- IQVIA (Boston, MA)
- **Manager, Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... of innovative medical treatments. Our diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies… more
- Takeda Pharmaceuticals (Lexington, MA)
- …device development teams + Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial ... and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role… more
- Takeda Pharmaceuticals (Lexington, MA)
- …readiness, data integrity, and continuous improvement, ensuring adherence to global regulatory expectations and Takeda standards. Our division-sponsored ... in a Master's program in Pharmacy, Pharmaceutical Sciences, Quality Management, Regulatory Affairs , Biomedical Sciences, or related discipline. + Foundational… more
