​Role: Senior Director EU Regulatory Affairs  

Industry: Pharma

Location: Europe

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Discovery
Our client, a fast-growing US-based pharmaceutical company, was expanding into Europe and establishing a new regional headquarters to drive regulatory, commercial and strategic operations. To support this expansion, the organisation sought to build a local leadership team capable of navigating the complexities of EU regulatory frameworks while maintaining the agility of a growing, entrepreneurial business. They required a Senior Director of EU Regulatory Affairs to:

• Lead regulatory strategy and submissions across multiple EU territories

• Partner with cross-functional teams to support product approvals and lifecycle management

• Establish regulatory processes suitable for a small, growing organisation entering a highly regulated market

The challenge lay in finding a leader with both EU regulatory expertise and experience working in smaller, fast-scaling pharmaceutical or biotech organisations. Many candidates had strong multinational experience but lacked the agility, adaptability and entrepreneurial mindset needed for a start-up environment, significantly narrowing the available talent pool.

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Reach
We conducted a European-focused executive search, mapping senior regulatory leaders across the UK, Germany, Switzerland and the Nordics. Our research targeted professionals with regulatory experience in small to mid-sized pharma or biotech companies, particularly those with hands-on EU market experience who could navigate EU regulatory complexity while thriving in a smaller, dynamic organisation.

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Assessment
Candidates were evaluated on technical proficiency, strategic leadership and cultural alignment with an entrepreneurial organisation entering a complex market. Close collaboration with the client ensured shared clarity on competencies, leadership expectations and long-term growth objectives for the new European HQ.

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Impact
We appointed a Senior Director of EU Regulatory Affairs based in the UK, bringing extensive multi-territory EU regulatory experience and a proven record of building agile regulatory teams. The new leader has established a strong regulatory foundation, enabling the client’s successful European market entry and supporting future commercial expansion.

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CONTACT US

Wherever they are in the world, we'll find them

Reach out to Shane Browne, Managing Director - International Operations(shane.browne@hrmrecruit.com).

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