Sr. Director, Regulatory Strategy

The role

The Senior Director of Regulatory Strategy will lead regulatory strategy and health authority interactions for a portfolio of gene therapies. This role involves defining regulatory frameworks, executing deliverables, and driving cross-functional alignment to support FDA and EU submissions.

What you will do

• Lead regulatory science activities and FDA interactions
• Develop and execute regulatory strategies for post-approval lifecycle management and new indications
• Lead cross-functional preparation for FDA meetings including Type B, C, and D
• Develop briefing books, meeting packages, and regulatory correspondence
• Advise cross-functional teams on FDA requirements and evolving policy
• Conduct regulatory assessments for product enhancements and manufacturing changes
• Lead strategic initiatives to obtain European Union approvals
• Develop the EU regulatory roadmap including PIPs and MAA readiness
• Manage the Regulatory Strategy team
• Support regulatory strategy for GCC partner company and oversee geographic expansion

Required qualifications

• Advanced degree in life sciences, pharmacy, medicine, regulatory science, or a related field
• Minimum 10 years of biotechnology or pharmaceutical industry experience
• Minimum 6 years of progressive regulatory affairs/regulatory strategy experience
• Demonstrated leadership of successful FDA interactions and major US regulatory submissions
• Experience with major ex-US health authorities, e.g., ICH countries
• Experience with biologics, cell therapies, gene therapies, or other advanced therapies
• Strong understanding of FDA regulations, guidance documents, and regulatory procedures
• Excellent written, verbal, and presentation skills
• Proven ability to influence senior leaders and drive decisions across functions

Nice to have

• PhD, PharmD, MD, or equivalent
• Direct experience with gene therapy products
• Experience supporting BLA approvals and post-marketing lifecycle management
• Prior experience engaging with EMA and European regulatory agencies
• Experience developing Pediatric Investigation Plans (PIPs)
• Regulatory experience in hematology, rare diseases, or genetic disorders
• Experience leading global regulatory teams and external regulatory consultants
• Experience working with lean resources in a nimble environment

Benefits

• Comprehensive health, life and disability insurance
• Employer-matched 401(k) plan
• Lifestyle spending account
• Flexible time-off
• Paid holidays
• Winter holiday period
• Tuition reimbursement & loan repayment assistance
• Paid parental leave
• Paid onsite parking
• Commuter subsidy

Before you apply

• Only candidates within commuting distance of Somerville will be considered

About the company

Genetix Biotherapeutics is pursuing curative gene therapies. The company values innovation, diversity, and cooperation.