- Parexel (Providence, RI)
- …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. (Providence, RI)
- …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
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …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
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of ... the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- … 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
- 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 (Framingham, 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