US-MA, Manager, Global Regulatory Affairs CMC Submissions Management R0011614-MZ
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Global Regulatory Affairs CMC Submissions Management in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Submissions Management team, you will be empowered to drive the Global CMC Submissions Team, and a typical day will include:
The Manager of GRA CMC Submission Management (CSM) R&D drives the Global CMC Submissions Team for Development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes for where R&D deliverables are needed for commercial/GMS regulatory submissions the Research and Development (R&D) Division by managing a team of subject matter experts including Pharmaceutical Sciences representatives, Quality representatives, and cross-functional stakeholders in Regulatory. The manager establishes the document plan, negotiates timelines with authors, drives all deliverables against the timeline, compiles all submission ready documents, and delivers the final submission components to the Publishing team. Where R&D deliverables are needed for commercial/GMS regulatory submissions, the Manager collaborates with the CSM Lead in Global Manufacturing and Supply (GSM) to prioritize documents, drive the timeline and manage the R&D stakeholders. The Manager ensures all deliverables are prioritized and tracked and delivered on time, escalates issues where they are identified, and provides strategic insight on issue resolution.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience Required:
WHAT TAKEDA CAN OFFER YOU:
Empowering Our People to Shine
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