Regulatory Affairs Manager – EU CMC Lead

We are looking for an experienced Regulatory Affairs Manager – EU CMC Lead to provide regulatory CMC leadership across complex client programs.

In this role, you will lead CMC regulatory activities from planning through delivery, working with cross-functional and global teams including Regulatory CMC colleagues, Technical SMEs, dossier authors and submission teams.

You will provide regulatory guidance, coordinate key deliverables and timelines, manage risks, and act as a trusted regulatory partner to clients.

You will also contribute to new business opportunities, supporting proposals, client presentations and bid defenses from a Regulatory CMC perspective.

Key Responsibilities

• Lead the planning and delivery of complex CMC regulatory activities across products, dossiers and markets.
• Provide regulatory CMC guidance on dossier requirements, CTD/Module 3 content and Health Authority expectations.
• Review CMC documentation from development, manufacturing and technical teams from a regulatory perspective.
• Coordinate CMC deliverables, timelines, dependencies, risks and responses to Health Authority questions.
• Lead cross-functional teams in a matrix environment, ensuring clear responsibilities, priorities and accountability.
• Facilitate CMC project meetings, document reviews and resolution of technical and regulatory comments.
• Act as a key client-facing Regulatory CMC contact, providing clear updates and regulatory recommendations.
• Translate client requirements into practical delivery plans, timelines and resource needs.
• Support RFPs, proposals, scope development, resource estimates, client presentations and bid defenses.
• Proactively identify project, quality, capacity and timeline risks and develop appropriate mitigation plans.
• Provide guidance and support to less-experienced team members.
• Support effective use of regulatory document-management systems, including Veeva Regulatory Vault.

Qualifications

• Degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Biotechnology or another relevant scientific discipline.
• Typically 5+ years of Regulatory Affairs/CMC experience, including responsibility for complex CMC activities.
• Strong knowledge of EU CMC regulatory requirements, MAA dossier structures, CTD and Module 3.
• Experience supporting regulatory dossiers and responses to Health Authority questions.
• Good understanding of pharmaceutical manufacturing, controls and their regulatory implications.
• Demonstrated experience leading projects and cross-functional teams in a matrix environment.
• Strong project-management, planning, risk-management and problem-solving skills.
• Strong client-facing communication and stakeholder-management skills.
• Experience supporting proposals, RFPs, new business opportunities, client presentations or bid defenses is highly desirable.
• Experience with regulatory document-management systems; Veeva Regulatory Vault experience is an advantage.
• Ability to manage multiple projects and priorities while working effectively across global teams.