Blackfield Associates
Senior Manager Regulatory Affairs
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
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 a 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.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
Regulatory Due Diligence & Portfolio Development
- 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.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
Requirements
- 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 specialty products (Injectables or innovative 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.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Location