- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing … more
- Astellas Pharma (Northbrook, IL)
- …Regulatory Affairs , Quality Assurance, Business Partners). Responsible for developing regional/ global CMC regulatory strategy (eg, CMC ... apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with...**Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...in initiatives internal to RA CMC . Represents CMC regulatory affairs on project… more
- Sumitomo Pharma (Springfield, IL)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing ... the company's global regulatory strategy to support clinical development,...activities. Cross-Functional Collaboration * Collaborate closely with Clinical Development, CMC , Medical Affairs , and Commercial teams to… more
- Parexel (Springfield, IL)
- …and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge ... to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as...experience is required. * Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. *… more
- Parexel (Springfield, IL)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life… more
- Lundbeck (Deerfield, IL)
- …- open to candidates in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the ... Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements ( CMC...field. Doctorate Degree or MBA, other professional certifications. + Global Regulatory Affairs Experience. +… more
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... quality and analytics is required. + Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. + Ability to influence… more