Director, Regulatory Science (Biologics & Cell & Gene Therapies Development)

Director, Regulatory Science – Biologics & Advanced Therapies

Science-led. Human-driven. Shaping what’s next.

The Future Is Already Here — Help Us Shape It

The next generation of medicine is unfolding — biologics, cell and gene therapies, and advanced modalities are redefining what’s possible in healthcare.
At VCLS, we partner with those leading this transformation: pioneering biotech and healthtech innovators pushing the boundaries of science to bring breakthroughs to patients.

We’re seeking a Director, Regulatory Science – Biologics & Advanced Therapies to play a pivotal role in this mission.
This is a rare opportunity to combine scientific depth, regulatory strategy, and leadership influence — helping visionary companies navigate complex global pathways while developing the next wave of talent at VCLS.

If you’re a scientifically fluent Regulatory Affairs consultant with a deep understanding of ATMPs, biologics, or gene and cell therapies, and if you’re driven by purpose, collaboration, and curiosity, this role will give you the scope and stage to make a lasting impact.

What You’ll Do

Shape the Future of Regulatory Science

• Lead a diverse portfolio of biotech and healthtech clients developing cutting-edge biologics and cell & gene therapies.
• Design and deliver innovative, global development strategies aligned with evolving regulatory frameworks and emerging technologies.
• Build long-term client partnerships grounded in trust, insight, and shared ambition.
• Represent VCLS in discussions with health authorities, leveraging your expertise to unlock new pathways to approval.
• Mentor and grow a talented team of Regulatory Scientists, cultivating consulting excellence and scientific rigor.
• Challenge assumptions and simplify complexity — transforming uncertainty into clear, actionable strategy.

Lead with Vision and Purpose

• Serve as a cultural and scientific leader within our US and global network, living our PIPE values — People, Innovation, Passion, and Excellence.
• Foster connection, creativity, and collaboration across teams and geographies.
• Champion the integration of regulatory and scientific thinking across the business.
• Act as a visible thought leader in the advanced therapies space — contributing to conferences, publications, and strategic forums.

Drive Growth and Collaboration

• Cultivate strategic relationships with clients, partners, and industry peers.
• Support business development activities — from proposals and presentations to networking and thought leadership.
• Collaborate cross-functionally to build integrated solutions that reflect the full scope of VCLS’s expertise — from discovery to patient access.

Why Join VCLS?

Impact.
Work on programs that push the limits of science — helping bring transformative therapies to patients worldwide.

Vision.
Be part of our bold ambition: to help deliver 500 life-changing healthtech products by 2050.

Culture.
No silos. No politics. Just people united by curiosity, purpose, and a shared belief that great science deserves great partners.

Opportunity.
Lead globally, influence strategically, and grow in an environment that values both excellence and humanity.

• Advanced degree in a scientific discipline (e.g., Ph.D., MD, Pharm.D.) or related field.
• 12+ years of experience in regulatory science with leadership expertise and creative thinking.
• Track record of close interactions with FDA in the context of biologics and cell and gene therapies development.
• A senior regulatory science professional with deep expertise in biologics and cell & gene therapy development.
• Experienced in consulting, able to balance strategy, client delivery, and business growth.
• A strategic thinker with a bias for action, energized by solving complex regulatory challenges.
• A skilled communicator and relationship builder, comfortable advising executives, clients, and regulators.
• A mentor and leader, passionate about developing people and inspiring teams.
• Aligned with our PIPE values and motivated by the chance to leave a legacy in healthcare.