Hlx Life Sciences
Senior Manager Regulatory Affairs
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Senior Manager, Regulatory Affairs (Europe)
Location: Berkshire
Working model: Hybrid
Reports to: Associate Director, Regulatory Affairs
Type: Permanent, full-time
A specialty pharmaceutical business is adding a newly created role to its European regulatory team. You'd take end-to-end ownership of a small portfolio, from strategy and submission through to approval and lifecycle, reporting directly to the Associate Director.
Submissions, approval and lifecycle
- Lead centralised procedure MAAs to the EMA, and the corresponding MHRA submissions for the UK
- Own responses through the assessment clock to grant
- Set regulatory strategy for assets entering the European portfolio
- Prepare paediatric investigation plans and lead scientific advice with the EMA and MHRA
- Manage lifecycle maintenance, variations and post-approval commitments, including orphan products
- Manage or guide less experienced members of the team
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- Act as the regulatory voice in cross-functional assessment of in-licensing and acquisition targets
- Review existing scientific advice documentation and interpret what it commits a programme to
- Critically review dossiers (Modules 1–5) to identify gaps, risks and issues likely to surface at assessment
- Advise the business on whether to progress an asset, working alongside clinical, safety, quality, commercial and market access
What you'll need
- 5–10 years in regulatory affairs within an innovative pharmaceutical environment
- Personally led a centralised procedure MAA end to end through to grant — this is essential, not preferred
- MHRA submissions and UK requirements post-Brexit
- Experience leading or coordinating scientific advice procedures with the EMA and/or MHRA
- Lifecycle maintenance and variations across EU and UK
- Strong grasp of European regulatory requirements for specialty products; experience in ophthalmology, neurology, respiratory, complex injectables or other innovative formulations is an advantage but not a filter
- Degree or higher degree in pharmacy or life sciences
- Collaborative, and able to hold a regulatory position across functions and geographies
- Right to work in the UK - sponsorship is not available for this role
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