Regulatory Affairs Scientist - CMC, US - Raleigh (NC) - M

CROMSOURCE - Raleigh, NC - Description: Title: Regulatory Affairs Scientist - CMC Location: Raleigh, NC Schedule: Full-time CROMSOURCE is looking for an experienced Regulatory Affairs Scientist to join one of our biotechnology partner companies in the US, based either in Raleigh, NC or Atlanta, GA. The Regulatory Affairs Scientist will be responsible for supporting global submissions for all phases of the product (phase I - III, MAA/BLA/NDA and post approval), including defining the strategy, planning and preparation of region-specific CMC submission documentation for assigned geographical regions and contributing to the preparation of global submission documentation to deliver timely approvals to meet business needs. This opportunity is open to both employees and freelance applicants. The successful candidate will be working on studies dedicated to one client . We are looking for someone with strong project management skills with Phase I studies, who is able to act quickly, make well considered decis... - Permanent - Full-time

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