Senior Manager Regulatory Affairs
Job Description & How to Apply Below
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
.KeyResponsibiliti
- esLead regulatory due diligence activities for potential in-licensing and business development opportunitie
- s.Conduct detailed gap analyses of CTD Modules 2, 4 & 5, reviewing clinical and non-clinical data packages to assess regulatory viability within Europ
- e.Evaluate development programmes, regulatory risks, data gaps, and probability of approval for innovative products and NCE
- s.Develop EU and UK regulatory strategies for early and late-stage asset
- s.Support interactions with EMA and MHRA, including Scientific Advice activitie
- s.Contribute to Centralised Procedure submissions, approvals, and lifecycle management activitie
- s.Partner closely with Regulatory, Clinical, CMC, Commercial and Business Development teams to support investment and development decision
- ce:5+ years' experience within Regulatory Affairs in the pharmaceutical indust
- ry.
Experience supporting innovative products, small molecules and/or NC - Es.Prior involvement in regulatory due diligence, asset assessments, gap analyses, or in-licensing activiti
- es.
Experience reviewing and assessing Modules 2, 4 and 5 of regulatory dossie - rs.
Strong knowledge of European regulatory requirements and development pathwa - ys.
Hands-on experience with EMA Centralised Procedure submissio - ns.
Background gained within innovative pharmaceutical or biotechnology compani
This is a full time, permanent position, based on a hybrid (3 Days per week) office presen
ce. Unable to offer Sponsors
hip Strategic, highly visible role supporting portfolio growth and innovat
ion.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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