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Director / Sr. Director, Regulatory CMC
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- Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing.
- The primary responsibilities are to develop and execute global (with an emphasis on US and EU) CMC regulatory strategies towards regulatory adoption of innovative approaches to biologics product and process design, and manufacturing; to lead and manage CMC matters for internal and external products and
- With an emphasis for the US and EU, interpret global CMC regulations and provide strategic direction and regulatory guidance that are relevant to biotherapeutic technologies, products and systems being developed by Discovery, Process Development, Quality and Manufacturing
- Lead and manage of Chemistry, Manufacturing & Controls (CMC) components for products in early-to-late stage development including novels, biosimilars and cellular therapies
- Develop innovative strategies and provide Regulatory Affairs input for clients and business partners on all CMC related matters
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