- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- AbbVie (North Chicago, IL)
- …works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and ... teams to negotiate, influence, and provide strategic advice. Responsibilities: + Prepares CMC regulatory product strategies. Prepares and manages regulatory … more
- AbbVie (North Chicago, IL)
- …internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited ... to peers in RA, R&D, and Operations. Additional responsibilities include: + Prepares CMC regulatory product strategies with limited supervision. + Prepares … more
- Sumitomo Pharma (Springfield, IL)
- … Team (GRT) + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Regulatory Affairs** . The Senior Manager is part of the Global … more
- AbbVie (North Chicago, IL)
- …and Controls ( CMC ) dossier strategy and authoring to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. Responsibilities ... include working with the CMC project team and external stakeholders to develop cutting-edge...strategy to health authorities, contributes to the preparation of regulatory query responses and briefing books, and serves as… more
- AbbVie (North Chicago, IL)
- …delivering diligence project objectives. + Stay abreast of developments in global CMC technical, regulatory and compliance arena and industry practice ensuring ... is responsible for representing Development Sciences Chemistry Manufacturing & Controls ( CMC ) space to Corporate Licensing and Acquisitions (L&A) in the evaluation… more
- AbbVie (North Chicago, IL)
- …documents of high scientific and technical quality that are compliant with global regulatory requirements. Partners with CMC teams during the development of ... (https://www.tiktok.com/@abbvie) . Job Description This position participates in global regulatory dossier preparation activities by gathering information from internal… more
- Merck (Springfield, IL)
- …and Technology or Technical Operations + Experience in authoring and reviewing CMC regulatory documentation + Excellent interpersonal that enable effective ... other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory - CMC , and Supply Chain, etc.) + Ensures that TT team… more
- AbbVie (North Chicago, IL)
- …of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content. Chemical/Bio Engineers within Process Engineering support pipeline ... clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions… more
- AbbVie (North Chicago, IL)
- …Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Mentor/supervise a team to support the ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
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