- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications… 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)
- …approaches to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + ... Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution across functions… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… 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. ... and timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical… 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 ... + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge...and/or parenterals). + Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions… 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...Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
- Sanofi Group (Waltham, MA)
- …Links with other internal and external stakeholders (such as R&D compliance, Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior ... diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D… more
- Bristol Myers Squibb (Devens, MA)
- …projects. + Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale ... of data trending, review and approval of change controls and preparation of regulatory filings. + Performs root cause investigations and develops CAPAs as needed for… more
- Takeda Pharmaceuticals (Boston, MA)
- …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and… more
- Bristol Myers Squibb (Cambridge, MA)
- …program goals in compliance with GCP, ICH and other global regulatory requirements + Provides comprehensive strategic leadership for 2,100+ multi-site organization ... experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and… more