Senior Manager Regulatory Affairs

Blackfield Associates; Slough; Hybrid; GBP 110,000 - 140,000; Full time

Job summary

Blackfield Associates in the United Kingdom is seeking a Senior Regulatory Affairs Manager to drive EU regulatory strategy, due diligence, and in-licensing evaluations for innovative medicines. The role shapes regulatory pathways, assesses external assets, and guides development programs toward successful approvals.

The candidate will lead interactions with EMA and MHRA, support centralised submissions, and collaborate with cross-functional teams to inform investment decisions and portfolio

Qualifications

• 5+ years' experience within Regulatory Affairs in the pharmaceutical industry.
• Experience supporting innovative products, small molecules and/or NCEs.
• Involvement in regulatory due diligence, asset assessments, or in-licensing activities.
• Experience reviewing Modules 2, 4 and 5 of regulatory dossiers.
• Strong knowledge of European regulatory requirements and development pathways.
• Hands-on EMA Centralised Procedure submissions experience.
• Background in innovative pharmaceutical or biotech companies.

Responsibilities

• Lead regulatory due diligence activities for potential in-licensing and business development opportunities.
• Conduct gap analyses of CTD Modules 2, 4 & 5, reviewing data packages to assess regulatory viability within Europe.
• Evaluate development programmes, regulatory risks, data gaps, and probability of approval for innovative products and NCE.
• Develop EU and UK regulatory strategies for early and late-stage asset.
• Support interactions with EMA and MHRA, including Scientific Advice activities.
• Contribute to Centralised Procedure submissions, approvals, and lifecycle management activities.
• Partner with Regulatory, Clinical, CMC, Commercial and Business Development teams to support investment and development decisions.

Skills

Regulatory affairs

EU regulatory strategy

Due diligence

In-licensing

CTD module analysis

Stakeholder collaboration

Job description

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 Responsibiliti

• 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

s.Required Background & Experien

• 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

es.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.