- Parexel (Springfield, IL)
- …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. (Springfield, IL)
- …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
- Merck (Springfield, IL)
- …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
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …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. (Springfield, IL)
- … 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 (North Chicago, IL)
- …program execution strategies with clearly defined deliverables and milestones. The program manager is to kick-off project /transfer teams, remove barriers to ... with experience in drug substance and/or drug product transfers. The program manager is to provide strategic oversight for one or more industrialization programs,… more