Director/Senior Director, Regulatory Affairs CMC-Remote

Location: Remote, USA

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​If you have a true passion for science and want to be part of a cutting-edge organisation to lead Regulatory CMC strategies for novel products, then this is the opportunity for you.

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In this role, you will act as the Regulatory CMC lead to provide strategic guidance for cross-functional CMC & global regulatory teams. As this organisation are within the Gene Therapy space, you will be working to develop strategies where minimal regulatory precedent has been set, so you must be ready to embrace that challenge. You will act as the CMC subject matter expert when leading & supporting health authority interactions, along with ensuring that all CMC documentation is complete and up to standard.

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Our client have offices on both the East Coast (Boston) and West Coast (San Francisco), therefore this opportunity offers flexibility between being based in one of the office locations or working on a remote basis with the ability to travel to the office as and when for relevant meetings.

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Skills & Experience:

• 8+ years Life Science experience / 5+ years Regulatory Affairs CMC experience

• Knowledge of health authority regulations and requirements (FDA, EMA etc), with the ability to articulate and apply this knowledge to regulatory CMC strategies.

• Working knowledge of eCTD requirements - IND, IMPD, BLA, NDA, MAA.

• Educated to at least Master’s level (chemistry, biology, biochemistry or related fields)

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If this sounds like the next step in your career, please apply today so that Chris Sinclair can review your profile and be in touch to discuss this further.

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Salary: $180,000 - $220,000 Per annum + Excellent benefits