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Senior Regulatory Affairs Manager - EU
Your new company
Our global biopharma client is seeking an experienced Senior Regulatory Affairs Manager to drive regulatory strategy and ensure compliant lifecycle management across investigational and marketed products. This is a high‑impact role, supporting both clinical trial approvals and post‑marketing maintenance throughout the EU and wider region.
Your new role

• Lead regional input into global regulatory strategy, ensuring EU requirements are fully represented and implemented.
• Plan, manage and execute regulatory submissions—including CTAs / CTRs, MAAs, variations, renewals and labelling updates—in alignment with global filing plans.
• Develop regional regulatory documents, lead HA meetings, and provide expert guidance on pathways such as accelerated approvals, PIPs, Orphan Drug, FIH and compassionate use.
• Direct regional label strategy and negotiate with authorities to optimise commercial and scientific positions.
• Evaluate regulatory risks, advise global development teams, and coordinate responses to health authority questions.
• Ensure full post‑approval compliance, including fulfilment of commitments (IMRs, PMCs, paediatric obligations).
• Maintain awareness of evolving EU regulatory frameworks and assess competitive/regulatory intelligence to support strategic planning.
• Build and manage relationships with regional health authorities, ensuring proactive, high‑quality interactions.
• Where applicable, provide leadership and development to regional regulatory leads, ensuring optimal resource allocation and performance.

What you'll need to succeed

• Strong knowledge of EU regulatory legislation and procedures for CTAs, MAs, variations and lifecycle management.
• Deep understanding of drug development and regulatory strategy across multiple development stages.
• Proven experience with cross‑functional global teams and managing complex regulatory interactions.
• Ability to navigate ambiguity, resolve issues and drive solutions in a matrixed environment.
• Excellent communication, cultural awareness and stakeholder management skills.

What you'll get in return
Remote working with occasional trips to site

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.