Regulatory Affairs Manager – Central Regulatory Affairs (CRA), Europe

About the role

The Regulatory Affairs Manager – Central Regulatory Affairs (CRA) for Europe will lead regulatory strategy and execution across multiple European markets for a diverse portfolio of medicinal products, ensuring timely approvals and ongoing compliance.

Key responsibilities

• Develop and implement European regulatory strategies aligned with global objectives, supporting product registrations through centralized, decentralized, mutual recognition, and national pathways.
• Prepare and submit post‑approval lifecycle activities, including renewals, variations, Article 61(3) notifications and country‑specific updates.
• Maintain oversight of procedures, manage product portfolios developed internally, via partners or third‑party acquisitions, and ensure rapid market access.
• Collaborate with internal functions such as Clinical, Quality, Legal, Commercial, and Supply Chain to integrate regulatory requirements into product development and launch plans.
• Engage with health authorities (EMA and national competent authorities), building relationships to facilitate approvals and negotiate optimal outcomes.
• Support compliance and risk management by assessing regulatory changes, developing mitigation strategies, and addressing non‑compliance issues.

Required profile

• University degree in Pharmacy, Biotechnology or related scientific field; a Master’s in Regulatory Affairs is preferred.
• Minimum 5 + years of experience in Regulatory Affairs within the pharmaceutical industry.
• Fluent English (spoken and written) with strong interpersonal and communication skills.
• Proven ability to lead cross‑functional teams and manage complex regulatory projects across Europe.
• Experience with European regulatory procedures (CP, DCP, MRP, national filings) and post‑approval activities.