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. You will ensure timely approvals, licence maintenance and compliance for a diverse portfolio that includes generics, established brands, innovative and value‑added products.

Key responsibilities

• Develop and implement European regulatory strategies aligned with global objectives, partnering with internal and external stakeholders.
• Lead new product registrations through Centralised, Decentralised, Mutual Recognition and national procedures.
• Prepare and submit post‑approval lifecycle activities such as renewals, variations, Article 61(3) notifications and country‑specific updates.
• Collaborate with Clinical, Quality, Legal, Commercial and other functions to embed regulatory requirements into product development.
• Engage with health authorities (EMA and national agencies) to facilitate approvals and negotiate optimal outcomes.
• Monitor regulatory changes, assess impact and support risk‑mitigation strategies.

Required profile

• University degree in Pharmacy, Biotechnology or related scientific field; Master’s in Regulatory Affairs preferred.
• Fluent English (spoken and written) with strong interpersonal skills.
• Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical sector.

Required skills

• In‑depth knowledge of EU and national regulatory requirements and procedures.
• Experience managing product lifecycles, submissions and health‑authority interactions.