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Senior Manager Regulatory Affairs
Job Description & How to Apply Below
A growing speciality pharmaceutical business is expanding its European Regulatory Affairs team with the addition of a new Senior Regulatory Affairs Manager position.
In this role, you will be responsible for portfolio of innovative products, leading end to end submission / lifecycle and play a key role in evaluating in-licensing and acquisition opportunities, acting as the regulatory lead in due diligence activities.
Key Responsibilities Regulatory Strategy, Submissions & Lifecycle- Lead EMA Centralised Procedure Marketing Authorisation Applications (MAAs) from submission through approval.
- Manage corresponding MHRA submissions and UK regulatory requirements.
- Prepare and lead responses throughout the assessment process to successful grant.
- Develop regulatory strategies for new assets entering the European portfolio.
- Lead Scientific Advice procedures and Paediatric Investigation Plans (PIPs) with EMA and MHRA.
- Manage lifecycle activities, including variations, commitments, renewals, and orphan products.
- Support and mentor less experienced members of the Regulatory team.
- Act as the regulatory representative in cross-functional in-licensing and asset evaluation activities.
- Review Scientific Advice outcomes and assess development obligations and regulatory risks.
- Critically evaluate Modules 1–5 to identify gaps, deficiencies, and approval risks.
- Partner with Clinical, Safety, CMC, Commercial, Market Access, and Quality teams to support investment and go/no-go decisions.
- 5–10 years' Regulatory Affairs experience within an innovative pharmaceutical environment
- Hands-on experience leading a Centralised Procedure MAA end-to-end through approval (essential)
- Strong experience with EMA and MHRA submissions and post-Brexit UK regulatory requirements
- Experience managing or leading Scientific Advice procedures with EMA and/or MHRA
- Strong understanding of European regulatory strategy for speciality products (Injectables or inovative formulations)
- Degree in Pharmacy, Life Sciences, or related discipline
- Full right to work in the UK (sponsorship unavailable)
This is a full time permanent role, hybrid working from Slough.
Position Requirements
10+ Years
work experience
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