- 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)
- …innovation-driven 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 of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** **Title: Global Manufacturing Sciences BioProcess Lead ( Sr . Manager )** **Location: Zurich, Switzerland / Lexington, MA** ... the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products.… 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 (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
- Sanofi Group (Waltham, MA)
- …Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead, participates in project ... **Job Title:** Sr . Non-Clinical Biostatistician **Location:** Swiftwater, PA **About the...bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team… 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 (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... biologics portfolio. In this role, you will be a senior subject matter expert across one or more products...products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors...of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP… more