Regulatory Affairs Manager EU -12 months
Summary: A global biotech organization is seeking a Regulatory Affairs Manager for a 12-month contract, with the possibility of extension. The role is fully remote but requires the candidate to be based in the UK. The manager will oversee regulatory submissions and support multiple projects in development and marketed products across Europe.
Key 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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: Uxbridge
Country: UK
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
About the CompanyA 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.
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