Regulatory Affairs Manager – Post‑Approval MRP/DCP

About the role

We are seeking an experienced Regulatory Affairs professional to own the post‑approval life‑cycle strategy for a dynamic EU portfolio. This role sits at the intersection of CMC, regulatory strategy and cross‑functional collaboration, offering both strategic influence and hands‑on operational responsibility.

Key responsibilities

• Lead end‑to‑end post‑approval life‑cycle management including variations, renewals, labelling updates and aggregate reports.
• Prepare and submit EU variation applications via MRP/DCP and Workshare, handling complex submissions and super‑groupings.
• Develop submission strategies, select reference member states and define regulatory pathways.
• Support marketing authorisation applications for early‑stage innovation projects.
• Provide strategic regulatory input and CMC guidance to cross‑functional teams across EMEA.
• Ensure compliance with EU and global regulations, maintain inspection readiness and oversee regulatory documentation.

Required profile

• Proven experience in EMEA regulatory affairs, preferably in product life‑cycle management.
• Strong knowledge of EU procedures such as MRP/DCP, variations, PSUSA and aggregate reporting.
• Experience with work‑sharing and super‑grouping submissions.
• Demonstrated ability to develop and execute regulatory strategies for complex dossiers.
• Experience in line management or mentoring junior staff.
• Excellent stakeholder engagement and cross‑functional collaboration skills.

Required skills

• EU regulatory procedures (MRP/DCP, variations, PSUSA/aggregate reports)
• Work‑sharing and super‑grouping submission processes
• Regulatory strategy development
• CMC technical guidance

What we offer

• Flexible working options
• Opportunity to lead a small team on strategic projects
• Exposure to innovative and maintenance product portfolios across EMEA