Cambridge (Home working with some travels to Cambridge when needed) Permanent 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.
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.
Responsible for RA CMC focused agency negotiations and interactions, including scientific advice.
Lead a team of permanent employees within CMC regulatory.
Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio.
Qualifications Scientific based degree Proven pharmaceutical experience in regulatory or technical CMC Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners.
What we offer in return flexible benefits package opportunities for learning & development Diversity and inclusion Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority.
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Permanent