Regulatory Affairs Manager – EU (12‑month contract)

About the role

This is a 12‑month contract position, fully remote but based in the United Kingdom. You will support at least three projects, ranging from early‑stage development to marketed products, within a global biotech organisation.

Key responsibilities

• Manage Clinical Trial Applications (CTA), Marketing Authorisation Applications (MAA) and post‑approval regulatory submissions across Europe.
• Support the development of regulatory strategies for both pipeline and marketed products.
• Provide regulatory guidance to cross‑functional project teams.
• Interact with health authorities, including scientific advice and accelerated pathways.
• Contribute to labelling activities and life‑cycle management.
• Monitor regulatory changes and assess their business impact.
• Conduct regulatory intelligence to inform product development and submission planning.

Required profile

• Minimum 5 years of regulatory affairs experience in pharma or biotech.
• Strong knowledge of EU Clinical Trial Regulation (CTR) and MAA procedures.
• Understanding of drug development and life‑cycle management.
• Excellent communication and stakeholder‑management abilities.
• Based in the United Kingdom.

Required skills

• EU Clinical Trial Regulation (CTR)
• Marketing Authorisation Application (MAA) procedures
• Regulatory submissions
• Regulatory intelligence

What we offer

• 12‑month contract with the possibility of extension.
• Fully remote working arrangement.
• Opportunity to work on diverse projects within a leading biotech company.