Associate Director Regulatory Affairs

Apsida Life Science are currently partnering with a global biopharmaceutical company recognised for developing innovative medicines that address complex and serious diseases. The organisation combines strong scientific expertise with a patient-first approach, focusing on improving standards of care through breakthrough therapies and close collaboration with healthcare systems.

They are seeking an Associate Director, Regulatory Affairs.

Responsibilities

• Lead and manage a team of Regulatory Affairs professionals, providing guidance and strategic direction.
• Act as the primary interface with European Health Authorities, including EMA.
• Define and implement regulatory strategies across a portfolio spanning early development, late-stage, and marketed products.
• Provide leadership and regulatory support to affiliate teams across the European region.
• Drive delivery of regulatory submissions and ensure alignment with global and regional objectives.
• Collaborate cross-functionally to support product development, approvals, and lifecycle management.

Qualifications

• Significant experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Proven leadership experience managing and developing regulatory teams.
• Strong knowledge of European regulatory frameworks and Health Authority interactions (EMA).
• Experience across multiple stages of the product lifecycle (development to post-marketing).
• Excellent stakeholder management and cross-functional collaboration skills.
• Strong strategic mindset with the ability to drive regulatory outcomes in a complex environment.

Position Highlights

• Leadership role managing and developing a high-performing Regulatory Affairs team across Europe.
• Strategic ownership of a diverse product portfolio spanning early development through to marketed assets.
• Direct interaction with EMA and European Health Authorities, influencing key regulatory outcomes.
• Opportunity to work within a globally recognised biopharma with strong R&D investment and pipeline.
• High visibility role with cross-functional collaboration across global and regional teams.
• Hybrid working model within a supportive, collaborative, and innovation-driven environment.

If you are interested in learning more, please contact Geneva Jones at Apsida Life Science: Geneva.Jones@apsida.com

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