- Parexel (Boston, MA)
- …innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, ... requirements. Project Management: Serve as the project manager for meetings, adhering to best...Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing,… more
- 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 (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager ** **Location: Cambridge, MA (Hybrid)** **About the ... role:** As a CMC Project Manager , you will...& discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process. + knowledge, capability &… more
- Merck (Boston, MA)
- …Informatica Metadata Manager , Management Process, Process Flow Documentation, Project Management, Regulatory Documents, SAP Master Data Governance (MDG), ... development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations,… 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
- 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
- AbbVie (Worcester, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The MES Program Manager is an experienced leader responsible for managing large global projects ... multiple manufacturing locations. This individual provides leadership and coordinated project management for all manufacturing and/or technical activities needed to… 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
- Sanofi Group (Northborough, MA)
- …requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions + Knowledge and experience with ... coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations *...and purchasing systems in a CGMP manufacturing environment + Project management skills + Expertise in document management systems… more