- Sanofi Group (Framingham, MA)
- …supporting Sanofi's innovative pipeline of Mammalian and Gene Therapy products. The CMC Dossiers Leader will lead , coordinate, and manage CMC dossier ... **Job Title:** CMC Dossiers Leader **Location**...development of CMC dossiers with CMC activities to force fast-to-clinic/fast-to-patients objectives. + Lead… more
- Lilly (Philadelphia, PA)
- …of country specific CMC regulatory strategies + Author and review global CMC dossiers + Coordinate and contribute to responses to regulatory agency questions ... life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover… more
- Lilly (Philadelphia, PA)
- …Management (RIM) system) + Manage the preparation, review, and submission of global CMC regulatory dossiers and information request responses according to CMC ... life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover… more
- Amgen (Washington, DC)
- …filing requirements, submission strategy, and regulatory risk assessments + Develop global dossiers for CMC content for initial submissions, variations and ... proud of. **Regulatory Affairs Senior Manager - Regional Regulatory Lead ** **Live** **What you will do** Let's do this....do this. Let's change the world.The Regulatory Affairs Manager CMC Contributes to product teams and acts as product… more
- Gilead Sciences, Inc. (Washington, DC)
- …**JOB DESCRIPTION** + Serve as critical and recognized, internally and externally, thought leader and contributor to the CMC Regulatory Affairs Policy, Advisory, ... ready to make a direct impact. We believe every employee deserves a great leader . People Leaders are the cornerstone to the employee experience at Gilead and Kite.… more
- Sanofi Group (Waltham, MA)
- …Statistician- Vaccines **Location:** Waltham, MA **About the Job** As an experienced mRNA CMC Principal Statistician, you will lead and coordinate the team ... end data integration and advanced analytics (pre-clinical, biomarkers, process development, CMC , clinical) in the mRNA CoE. Deploying and exploiting digital… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …Clinical Development, and Deputy Director (DD), Chemicals, Manufacturing and Controls ( CMC ) to contribute to the continued development of the team's strategic ... and goals for the group What You'll Do + Define strategy for and lead the pandemic product development portfolio, working closely with the Deputy Director of… more
- Bayer (Whippany, NJ)
- …(CGT) Combination Products requires a Global Regulatory Expert who can lead Combination Product Asset Development projects to achieve global registration. The ... enable fastest path to first cycle approval (eg, core dossiers , IND, CTA, BLA, MAA, Technical Files, etc.); +..., IND, CTA, BLA, MAA, Technical Files, etc.); + Lead and/or participate in key new product development Regulatory… more