- 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
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ... business insights / analytics and other specialized regulatory functions (eg, device /combination products) to deliver Global Regulatory Strategy Outlines… more
- Sanofi Group (Cambridge, 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 (Waltham, 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...guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle.… 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
- 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
- Medtronic (Boston, MA)
- … Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities that are necessary in obtaining and/or maintaining ... assigned product family. This role partners with the international regulatory affairs group to support global...of FDA and MDR requirements. + Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13483) +… 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
- 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
- Eliassen Group (Boston, MA)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager, Med Device , R&D PMO, Design Changes** **Anywhere** **Type:** Contract...modifications and component exchange programs while navigating a complex, global matrix organization. The project has completed feasibility and… more
- Avania (Boston, MA)
- …- Regulatory & Market Access Interns x2 We are seeking two, part-time Medical Device Regulatory Affairs & Quality Interns to join the Advisory team for ... outreach efforts. + Content Development + Contribute to creation of medical device regulatory and quality-focused white papers, blogs, and marketing materials.… more
