- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** **About the role** The Principal Manager , R&D GMP Pharmaceutical Sciences Quality EU & US provides Quality oversight ... + Contribute technical quality content to regulatory filings and collaborate with CMC submission teams. + Participate as SME in external audits, support PAI… more
- Deloitte (Boston, MA)
- …Recruiting for this role ends on 12/20/2025 Work you'll do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... and generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Experience with cloud computing… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Sanofi Group (Northborough, MA)
- …planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations * Reporting of deviations to ... coverage targets to Critical Material Manager (GSP) + Reviews SAP requisitions or Site Scheduler...approval changes and of information typically found in the CMC sections of regulatory submissions + Knowledge and experience… more
- Parexel (Boston, MA)
- Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global ... regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life Sciences, Chemistry,… more
- Takeda Pharmaceuticals (Boston, MA)
- …on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget ... sub-teams, such as the Clinical Subteam, Commercial Subteam, Pharmaceutical Sciences ( CMC ) Subteam, etc. to the GPT through function-based subteam leaders to… more