Head of Regulatory Strategy - Europe

PEAK LIFECYCLES HR, dedicated to Life Sciences and global Care Markets, is part of Cornerstone International Group, ranked among the Top 40 Global Executive Search firms by Hunt Scanlon. Our global footprint combines international impact with deep local knowledge. We specialise in anticipating emerging skills, identifying new strategic expertise, and securing the leaders who will shape the future of the healthcare ecosystem

Head of Regulatory Strategy - Europe (Fast Track / PRIME readiness, Advanced Therapies)

Location: Europe (flexible)

Our client is an innovative biotech company currently progressing through accelerated regulatory pathways and preparing its European expansion. To support this strategic phase, we have been retained to recruit a Head of Regulatory Strategy Europe to lead high-level interactions with the EMA and shape the regulatory pathway towards market readiness for a breakthrough therapy.

This is a strategic leadership role with direct impact on patient access and on the advancement of an accelerated approval programme in Europe.

Key Responsibilities

• Define and lead the European regulatory strategy, with a focus on EMA engagement and accelerated approval pathways (Fast Track, PRIME, ATMP or similar).
• Drive scientific advice procedures and regulatory submissions at both central and national levels.
• Anticipate regulatory expectations and support preparations for early access frameworks and HTA evaluation (no commercial execution required).
• Shape the benefit–risk narrative and long-term lifecycle strategy in collaboration with clinical and medical affairs leadership.
• Act as the primary regulatory counterpart to European authorities and expert committees.

Candidate Profile

• Senior leadership experience in EU Regulatory Affairs within innovative biotech or advanced therapies under accelerated approval pathways.
• Proven track record managing Fast Track, PRIME, RMAT, conditional approval or equivalent regulatory procedures.
• Strategic understanding of regulatory trends influencing access to breakthrough therapies in Europe.
• Strong scientific and regulatory credibility, with the ability to influence internal and external stakeholders.
• Based in Europe (France, Belgium, Switzerland, Germany, UK – flexible European location).

What This Role Offers

• A high-impact strategic position within a rapidly growing biotech advancing a transformative therapy.
• The opportunity to shape the European regulatory pathway from an early strategic stage.
• A confidential and influential leadership environment, working closely with executive management and regulatory authorities.