- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... States regulatory frameworks and global CMC strategy. This role will lead the...MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the… more
- Capgemini (Chicago, IL)
- …risk mitigation, ESG/EMA gateway submission processes. **Project Delivery** + Lead regulatory consulting programs: readiness assessments, strategy development, ... service line** : prospecting, qualification, proposals, and commercial negotiations. + Lead regulatory sales cycles (discovery → contract); write technical… more
- Lundbeck (Deerfield, IL)
- …in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of ... products/programs. + Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements ( CMC , Regulatory… more
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... Care group is seeking a motivated Scientist as a CMC drug product project lead , specifically for...+ Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence… more
- AbbVie (North Chicago, IL)
- …innovative medicines. In the course of our work, we collaborate with early-stage CMC , Quality Assurance, Regulatory Affairs , Internal and External ... for you. Key Responsibilities: + Create and maintain product design documentation + Lead design transfer and industrialization activities + Initiate and lead … more