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Director, Regulatory Science (Biologics & Cell & Gene Therapies Development)
Director, Regulatory Science (Biologics & Cell & Gene Therapies Development)VCLS • Cambridge, MA, US
Director, Regulatory Science (Biologics & Cell & Gene Therapies Development)

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

VCLS • Cambridge, MA, US
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Job Description

Job Description

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.

    Requirements

  • 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.
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