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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.