Blackfield Associates
Senior Manager Regulatory Affairs
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Senior Manager Regulatory Affairs
Senior Regulatory Affairs Manager – Europe
(Growing Pharma!)
We are seeking an experienced Senior Regulatory Affairs Manager to lead regulatory strategy and due diligence activities for speciality products across Europe.
This position sits at the intersection of regulatory strategy, business development, and in-licensing evaluation, supporting the assessment of late-stage development assets and defining optimal pathways to approval across the EU and UK. The role offers significant exposure to innovative products and complex regulatory decision-making.
Key Responsibilities
- Lead regulatory due diligence activities for in-licensing opportunities across speciality therapeutic areas, including Phase II and Phase III development assets.
- Evaluate the suitability of assets for EU and UK development and future Marketing Authorisation approval.
- Critically review and assess clinical, non-clinical, and regulatory data packages, identifying potential gaps, risks, and opportunities that may impact approval success.
- Define and recommend EU and UK regulatory strategies, including:
- Development pathways
- Risk mitigation plans
- Regulatory timelines
- Collaborate with cross-functional teams including:
- Clinical Development
- Non-Clinical
- CMC
- Commercial
- Business Development
- External partners
- Support and contribute to Scientific Advice interactions with EMA and MHRA.
- Prepare and review Marketing Authorisation Applications (MAAs) and support regulatory approval activities.
- Manage post-approval regulatory activities, including:
- Variations
- Commitments
- Interactions with health authorities
- Provide strategic regulatory input into investment, licensing, and portfolio decision-making.
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Background and Experience
The ideal candidate will have:
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5–10+ years of Regulatory Affairs experience within the pharmaceutical industry.
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Strong experience in:
- Regulatory strategy
- Due diligence
- EU/UK submissions
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Proven, hands-on experience in due diligence and gap analysis of the following dossier sections as essential:
- Module 2
- Module 4
- Module 5
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Expertise in:
- European regulatory requirements
- Development pathways for innovative pharmaceutical products
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Experience supporting:
- Scientific Advice procedures
- MAA (Marketing Authorisation Applications) submissions
- Approval processes
- Lifecycle management activities
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Experience assessing regulatory, clinical, and non-clinical data packages to support strategic decision-making.
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Knowledge of speciality product development in areas such as:
- Neurology
- Respiratory
- Ophthalmology
- Inhalation products
- Complex injectables
- Other innovative formulations
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Degree in:
- Pharmacy
- Life Sciences
- Related scientific discipline
Candidates Must Include
- Due diligence and asset evaluation for in-licensing opportunities for:
- New Chemical Entity
- Small molecule development
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