Regulatory Affairs Head of CMC
At Mundipharma, a global healthcare company focusing on pain management, infectious disease and other severe disease areas, we are seeking an experienced regulatory professional to lead our Regulatory Affairs – CMC team.
Role and Responsibilities
This role leads the RA CMC team, overseeing employees and vendors to deliver regulatory CMC product strategy and deliverables across EU and Remaining‑World markets. Key responsibilities include:
- Responsible for RA CMC deliverables for products including RA CMC product strategy and oversight of vendor delivery.
- Ensure that RA CMC strategies fully recognize risk, provide mitigations and communicate these to product teams.
- Act as the primary contact for internal RA CMC queries from technical and quality teams, including due diligence and regulatory agency interactions, to resolve issues efficiently and support decision‑making.
- Ensure all regulatory processes, controlled documents and knowledge resources are accurate, up‑to‑date, and consistently applied, supporting compliance and alignment with broader regulatory objectives.
- Manage the team of employees and vendors to deliver high‑quality regulatory outcomes by setting clear objectives, providing guidance, and monitoring performance to maintain operational efficiency and accountability.
What you’ll bring
- 10 years pharmaceutical experience in regulatory or technical CMC.
- 2 years regulatory CMC experience.
- Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management.
- Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners.
- Strong organizational and problem‑solving skills.
- Self‑motivated, driven with a positive attitude.
- Excellent communicator and collaborator with strong customer and stakeholder focus.
- Ability to effectively motivate and manage a team to deliver RA CMC objectives.
What we offer in return
- Opportunities for learning & development through our varied programme.
- Collaborative, inclusive work environment.
- Competitive compensation and benefits package.
- Opportunity to make a meaningful impact on patient care.
Diversity and inclusion
We are committed to building an inclusive environment where people can thrive, grow and achieve their full potential. All qualified applicants will receive consideration for employment regardless of race, colour, religion, gender, gender identity, sexual orientation, national origin or disability.
About Mundipharma
Mundipharma is a global healthcare company focusing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. We bring innovative treatments to patients in areas of pain management, infectious disease and other severe disease areas. Our guiding principles centre on integrity and patient‑centricity.
Location
Cambridge, England, United Kingdom
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