Senior Manager Regulatory Affairs

Senior Regulatory Affairs Manager – Europe. Hybrid, perm role. 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, and regulatory timelines.
• Collaborate with cross-functional teams including Clinical Development, Non-Clinical, CMC, Commercial, Business Development, and 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, and interactions with health authorities.
• Provide strategic regulatory input into investment, licensing, and portfolio decision-making.

Background and Experience:

• 5–10+ years of Regulatory Affairs experience within the pharmaceutical industry.
• Strong experience in regulatory strategy, due diligence, and EU/UK submissions.
• Proven, hands on experience due-diligence/gap analysis of the Modules 2, 4 and 5 sections of the dossier for new in-licensed molecules is essential
• Expertise in European regulatory requirements and development pathways for innovative pharmaceutical products.
• Experience supporting Scientific Advice procedures, MAA submissions, approval processes, and lifecycle management activities
• Experience assessing regulatory, clinical, and non-clinical data packages to support strategic decision-making
• Knowledge of speciality product development, including areas such as Neurology, Respiratory, Ophthalmology, Inhalation Products, Complex Injectables, or other innovative formulations.
• Degree in Pharmacy, Life Sciences, or a related scientific discipline.

Candidates applying must have Due diligence and asset evaluation for in-licensing opportunities for New Chemical Entity and small molecule development.