- Parexel (Jefferson City, MO)
- …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. (Jefferson City, MO)
- …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
- Otsuka America Pharmaceutical Inc. (Jefferson City, MO)
- …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
- Otsuka America Pharmaceutical Inc. (Jefferson City, MO)
- … 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
- Catalent Pharma Solutions (Kansas City, MO)
- …Management Systems (QMS) to assure the site/division is compliant with regulatory , Corporate, and customer requirements. They are responsible for establishing and ... Quality. The Director of Quality is responsible for providing project guidance and support and work with customers to...business partner to Operations and advisor to the General Manager of the site. Location: Kansas, City, MO on-site… more
