- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings,...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Takeda Pharmaceuticals (Boston, MA)
- …reports + investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant ... development and clinical supply processes. + Demonstrated experience authoring CMC sections for regulatory submissions (eg, IND/IMPD/NDA/MAA). +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA / Zurich,… more
- Parexel (Boston, MA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... data, and drive data-based decisions and solutions. + Experience contributing to regulatory filings for biologics (eg, CMC sections, control strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible ... unit leaders + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge is captured, shared, and reused across… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... The Senior Manager , Global Product Quality - Biologics is responsible...in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role… more