Regulatory Affairs Director

We are proud of the work we do to bring innovative treatments to patients at Mundipharma. To deliver more for our customers, healthcare professionals, partners, and employees, we challenge ourselves constantly.

The role of CMC Director involves efficiently managing and delivering Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. This includes building and maintaining a strong collaborative partnership with products teams, especially with Tech Ops and Quality team members. The Senior Oversight role ensures effective delivery of CMC support from vendors. Additionally, the position leads a team of permanent employees (CMC regulatory) and supervises contractors and consultants supporting the CMC regulatory objectives and deliverables.

• Evaluate RA CMC strategies to ensure they fully recognize risk, provide mitigations, and communicate these within the organization for product team decision making.
• Lead RA CMC focused agency negotiations and interactions, including scientific advice.
• Manage a team of permanent employees within CMC regulatory, setting clear performance and development objectives and ensuring the delivery of assigned RA CMC objectives on their portfolio.

• Scientific based degree
• Proven pharmaceutical experience in regulatory or technical CMC
• CMC technical experience
• Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management
• Ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners
• Effective motivation and management of a team to deliver RA CMC objectives

• Flexible benefits package
• Opportunities for learning & development
• Collaborative, inclusive work environment