- Sanofi Group (Framingham, MA)
- …including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, managing ... + Act as direct liaison with agencies like US FDA and EMA + Develop positive relationships with regulators...documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality… more
- Carrier (Beverly, MA)
- …Regulatory Intelligence & Monitoring** + Interpret and monitor global regulatory requirements (eg, CE/MDR, FDA , ISO standards, environmental/transport ... + Regulatory Affairs Certification (RAC) or equivalent professional certification + Regulatory Knowledge on US: FDA , FCC; EU: MDR, Radio Equipment Directive,… more
- GRAIL (Boston, MA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses. + Demonstrate understanding of the major ... affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA ...in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and… more
- ThermoFisher Scientific (Waltham, MA)
- …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... experience strongly preferred. **Knowledge, Skills, Abilities:** + Extensive knowledge of regulatory requirements, including those from the FDA , Health Canada,… more
- Parexel (Boston, MA)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront...activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS 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 a ... Content Development + Contribute to creation of medical device regulatory and quality -focused white papers, blogs, and...skills. + Interest in medical device regulation, ISO 13485, FDA QSR/QMSR, and EU MDR/IVDR. + Proficient in Microsoft… more
- Pfizer (Cambridge, MA)
- …Finance, PX, , Legal, and PGS + Works with external contacts including Regulatory Authorities ( FDA , EMA, MHLW etc), professional scientific and regulatory ... **JOB SUMMARY** Global Regulatory Sciences (GRS) serves as strategic leader and...(GRS) serves as strategic leader and catalyst enabling high quality , efficient, innovative, label-focused global development that changes patient… more
- Parexel (Boston, MA)
- …Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) * ... opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This… more