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Permanent

Director of CMC - Marketed Products

Cambridge
money-bag 10000-500000 Annual
2853732370
Posted Yesterday

ARA-M4-14 Location: Cambridge (Home working with some travels to Cambridge when needed) Job type: Permanent At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. We are looking for a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The person will also be responsible for building and maintaining a strong collaborative partnership with products teams especially with team members from Tech Ops and Quality. They will act as Senior Oversight for RA CMC activities and ensure effective, quality delivery of CMC support from vendors.They will also lead a team of permanent employees (CMC regulatory) and supervise contractors and consultants supporting the CMC regulatory objectives and deliverables. Key Responsibilities Responsible for RA CMC for products including RA CMC strategy and oversight of vendor delivery. Ensure that RA CMC strategies fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate product team decision making. Escalation point for vendors for RA CMC strategy for products and review of delivery output from vendors to ensure that it is fit for purpose and in line with the strategic direction provided. Act as initial ..... full job details .....

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