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Director/Senior Director Regulatory Science CMC

Location: London, UK Reporting to: Sr. Director, Regulatory Science CMCJob summaryOrchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases.Key Elements and Responsibilities Serve as in-house regulatory CMC contact to internal parties and regulatory bodies. Participate in definition and implementation of CMC regulatory strategy, notably for Life-cycle management of Orchard's commercial and late-stage development products. Plan, author, and review, in collaboration with Tech Ops teams quality sections of dossiers to be submitted to regulatory authorities (including FDA, EMA and other national authorities) to support life cycle management of late-stage development and commercial products. Lead regulatory CMC activities for assigned projects in line with US, European, ICH, and other applicable requirements Work closely with internal Orchard Tech Ops functional groups an...

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Ad Id27089435
PostedNovember 20, 2020
Expiry December 20, 2020
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