Director of CMC for Marketed Products

2 months ago


Frampton on Severn Gloucestershire, United Kingdom Mundipharma Full time

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.
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.
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. Join our talent pool
If you're not sure this role is right for you but you're keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
Permanent



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