Regulatory Affairs Manager EU -12 months

About the Company

A global biotech organisation with a strong pipeline of development and commercial products across multiple therapeutic areas is looking for a 12-month reg manager to join the team with scope to extend. Fully remote but you must be based in the UK.

You will be responsible for supporting at least 3 projects, which could be in development or marked products.

Responsibilities

• Manage CTA, MAA and post-approval regulatory submissions across Europe.
• Support regulatory strategy for development and marketed products.
• Provide regulatory guidance to cross-functional project teams.
• Support interactions with health authorities, including scientific advice and accelerated pathways.
• Contribute to labelling activities and life cycle management.
• Monitor regulatory changes and assess business impact.
• Conduct regulatory intelligence to support product development and submission planning.

Requirements

• 5+ years Regulatory Affairs experience within pharma or biotech.
• Strong knowledge of EU CTR and MAA procedures.
• Understanding of drug development and LCM lifecycle management.
• Excellent communication and stakeholder management skills.

Please apply now or reach out to hear more details.