Hays Specialist Recruitment Limited
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.
To apply for this job please visit www.reed.co.uk.
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