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Director, CMC Regulatory Affairs Biologics
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$205,700 - $266,200
Full-time
- Director, CMC Regulatory Affairs – BiologicsKEY RESPONSIBILITIESThe Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio.
- This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions, and “right to operate” by maintaining the global clinical or commercial submissions.
- In addition, you will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.
- Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.
- Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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