Blackfield Associates
Senior Manager Regulatory Affairs
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Senior Regulatory Affairs Manager / EU Regulatory Strategy & Due Diligence
We're supporting an innovative pharmaceutical organisation as they expand their European Regulatory Affairs team with a Senior Regulatory Affairs Manager focused on regulatory strategy, due diligence, and in-licensing evaluations across speciality therapies. This is a unique opportunity for a regulatory professional who enjoys the strategic side of Regulatory Affairs and has experience assessing external assets, identifying development risks, and shaping regulatory pathways for innovative medicines.
Key Responsibilities
- Lead regulatory due diligence activities for potential in-licensing and business development opportunities.
- Conduct detailed gap analyses of CTD Modules 2, 4 & 5, reviewing clinical and non-clinical data packages to assess regulatory viability within Europe.
- Evaluate development programmes, regulatory risks, data gaps, and probability of approval for innovative products and NCEs.
- Develop EU and UK regulatory strategies for early and late-stage assets.
- Support interactions with EMA and MHRA, including Scientific Advice activities.
- Contribute to Centralised Procedure submissions, approvals, and lifecycle management activities.
- Partner closely with Regulatory, Clinical, CMC, Commercial and Business Development teams to support investment and development decisions.
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.
Required Background & Experience
- 5+ years' experience within Regulatory Affairs in the pharmaceutical industry.
- Experience supporting innovative products, small molecules and/or NCEs.
- Prior involvement in regulatory due diligence, asset assessments, gap analyses, or in-licensing activities.
- Experience reviewing and assessing Modules 2, 4 and 5 of regulatory dossiers.
- Strong knowledge of European regulatory requirements and development pathways.
- Hands-on experience with EMA Centralised Procedure submissions.
- Background gained within innovative pharmaceutical or biotechnology companies.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
This is a full-time, permanent position, based on a hybrid (3 Days per week) office presence. Unable to offer Sponsorship.
Strategic, highly visible role supporting portfolio growth and innovation.
“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
Skills
Location