- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC -...+ Serves as regulatory CMC representative on development and marketed product teams. + Responsible ... global programs from pre-approval or post-marketing. + Capability to interact with CMC technical experts regarding process development and analytical issues. +… more
- AbbVie (North Chicago, IL)
- …respect to time and budget. + Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard ... the clinical/regulatory development strategy and provide drug development experience and advice to the CMC ...planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission… more
- AbbVie (North Chicago, IL)
- …of pharmaceutical products in AbbVie facilities or in contract facilities. The director establishes goals that are consistent with development , manufacturing and ... in the pharmaceutical industry. + Strong background and expertise in drug development , marketed product support, technical issue resolution & related technical,… more
- AbbVie (North Chicago, IL)
- …R&D functions (SMARD/BARD), CMC Regulatory Affairs (RA), Quality Assurance (QA), CMC Coordination, Product Development Science and Technology (PDS&T), ... and aligns in close cooperation with stakeholders globally, phase-appropriate lean development processes, workflows, and GMP approaches for ARD cross-functionally. +… more
- AbbVie (North Chicago, IL)
- …products. Key internal leader and driver of regulatory policy and strategy; ensures development of creative and impactful global product strategies for each ... portfolio + Strong experience working with multiple functions (Ad/Promo, Labeling, CMC , devices, Clinical development , etc.) and cross functional teams and… more
- Danaher Corporation (Chicago, IL)
- …of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This ... report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing… more