Director, Global Regulatory Affairs – Cell & Gene Therapy Development

Job Title: Director, Global Regulatory Affairs – Cell & Gene Therapy Development

Location: Boston, Massachusetts | Hybrid / Remote Flexibility

Industry: Biotechnology / Advanced Therapeutics

Type: Full-time | Permanent

About the Opportunity:

We’re excited to partner with a pioneering biotechnology company developing transformative cell and gene therapies for rare genetic disorders and oncology. As the company advances multiple clinical-stage programs, we’re seeking an experienced regulatory affairs leader to drive global regulatory strategy and execution across the development portfolio.

This role offers the opportunity to lead innovative regulatory programs, work closely with senior executives, and directly influence the success of breakthrough therapies reaching patients worldwide.

Role Overview:

As the Director of Global Regulatory Affairs – Cell & Gene Therapy Development, you will be responsible for designing and implementing global regulatory strategies that support clinical development and registration activities for novel advanced therapy products.

You’ll act as the primary regulatory representative on cross-functional teams, ensuring alignment across CMC, clinical, nonclinical, and quality functions while leading interactions with global health authorities.

This is a high-impact, visible role for an individual who thrives in a science-driven, fast-paced environment and who is passionate about advancing innovative therapies through intelligent regulatory leadership.

Key Responsibilities

• Develop and execute global regulatory strategies for cell and gene therapy programs across early and mid-stage clinical development.
• Lead preparation, submission, and maintenance of regulatory documents including INDs, CTAs, briefing packages, and meeting requests.
• Serve as the regulatory lead for assigned programs, managing communications and meetings with FDA, EMA, MHRA, and other health authorities.
• Collaborate cross-functionally with clinical, CMC, nonclinical, and project management teams to ensure regulatory objectives are integrated into program plans.
• Monitor evolving global regulatory guidance relevant to advanced therapies and translate insights into proactive development strategies.
• Oversee external regulatory consultants and vendors to ensure quality, compliance, and consistency of submissions.
• Support due diligence, partnership discussions, and portfolio planning by providing regulatory perspective and strategic input.
• Mentor junior regulatory staff and contribute to the growth and development of the regulatory affairs function.

Qualifications & Experience

• Advanced scientific degree (PhD, PharmD, MSc, or equivalent) in a life science or regulatory discipline.
• 8–12 years of progressive regulatory affairs experience within biotechnology or pharmaceuticals, including direct experience in biologics or cell/gene therapy.
• Demonstrated success in authoring and managing IND/CTA submissions and health authority interactions.
• Strong working knowledge of FDA, EMA, and ICH regulations and guidelines related to ATMPs and biologics.
• Proven ability to operate effectively in cross-functional, matrixed teams and manage multiple projects simultaneously.
• Excellent communication, leadership, and strategic problem-solving skills.

What We Offer (Compensation & Benefits)

• Competitive Base Salary: aligned with experience and biotech market benchmarks.
• Annual Bonus Eligibility: performance-based.
• Equity Incentives: stock options or RSUs for long-term alignment.
• Comprehensive Benefits: medical, dental, vision, life insurance, and disability coverage.
• Retirement Plan: 401(k) with company match.
• Flexible Work Environment: hybrid or fully remote options within the U.S.
• Time Off: generous PTO, paid holidays, and wellness days.
• Professional Growth: leadership exposure, cross-functional collaboration, and advancement opportunities in a high-growth biotech.