- GRAIL (Boston, MA)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Rhythm Pharmaceuticals (Boston, MA)
- …required, and graduate degree is preferred. + At least 10 years of regulatory affairs experience in drug development within the pharmaceutical or biotechnology ... the individual will lead the creation and execution of regulatory strategies that are grounded in scientific principles, focused...required. + Strong experience with the US Food and Drug Administration ( FDA ) is essential. Experience working… more
- Parexel (Boston, MA)
- …looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A ... At **Parexel** , we don't just support drug development-we help shape it. As a **Senior/Vice... regulatory applications. + Previous experience with a regulatory agency (such as the FDA or… more
- Parexel (Boston, MA)
- …Adobe Acrobat, TVT, Promomats, and GLAMS. **Core Competencies:** + Knowledge of regulatory requirements relevant to drug development, global labeling, and ... markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for… 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 ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and device development and manufacturing. + Strong understanding of design control and regulatory requirements ( FDA , EMA, ISO, USP) for combination products and ... knowledge. **Job Description** **Title: Senior/Principal Engineer, Combination Products and Drug Delivery Devices** **Location: Cambridge, MA** **About the role:**… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current ... values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission… more
- Lilly (Boston, MA)
- …of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADERS), preparation for ... ability to progress new medicines as part of a drug development team. Responsibilities of the role include directing... FDA communication and resolution of regulatory issues, including regulatory response, from a… more
- Cardinal Health (Mansfield, MA)
- …method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA ). + Perform investigations ... GC, UV-Vis, Karl Fisher and dissolution testing to assess drug product stability. + Ensure accuracy and precision of...Out of Specification (OOS) test results as needed follow FDA guidelines. + Maintain compliance with relevant regulatory… more
- Sanofi Group (Cambridge, MA)
- …patient populations, limited historical data, regulatory pathways (eg, FDA /EMA accelerated approval, orphan drug designation), and innovative trial ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...therapy clinical trials, a rapidly evolving field with unique regulatory and methodological considerations. The intern will engage in… more