VP, Global Regulatory Strategy & CMC

Regulatory Jobs; Bedford (MA); Hybrid; USD 345,000 - 395,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Life, disability insurance

Parental leave

401K with company match

Unlimited vacation

Tuition assistance

Employee Stock Purchase Program (ESPP)

Job summary

Stoke Therapeutics, headquartered in Bedford, MA, is hiring a Vice President of Regulatory Strategy & CMC to lead global regulatory and CMC strategies across the portfolio. The leader will guide interactions with major agencies and supervise cross-functional teams from early development through commercialization.

The role requires 12+ years in biotech/pharma with 6+ years in leadership, a strong regulatory background, and experience with INDs, CTAs, IMDPs, and post-approval submissions.

Qualifications

• Ph.D., Pharm.D., MS or advanced degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Biotechnology, or related discipline preferred.
• 12+ years of progressive experience in biotechnology, pharmaceutical, or cell and gene therapy industries, with at least 6 years in a leadership capacity.
• Deep expertise in global Regulatory Affairs and CMC development.
• Demonstrated success leading major regulatory submissions and health authority interactions.

Responsibilities

• Provide oversight and guidance into development and implementation of integrated global regulatory strategies for Stoke programs.
• Lead teams responsible for INDs, CTAs, IMPDs, BLAs, NDAs, MAAs, and post-approval submissions.
• Serve as executive lead for interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global agencies.
• Provide strategic regulatory guidance to leadership and program teams on development pathways and risk mitigation.
• Monitor evolving regulatory requirements and assess impacts on development and commercial programs.

Skills

Regulatory leadership

Global regulatory affairs

CMC strategy

Executive presence

Cross-functional collaboration

Risk assessment

Education

Ph.D./M.S./PharmD in related field

Job description

Stoke Therapeutics, headquartered in Bedford, MA, is hiring a Vice President of Regulatory Strategy & CMC to lead global regulatory and CMC strategies across the portfolio. The leader will guide interactions with major agencies and supervise cross-functional teams from early development through commercialization.

The role requires 12+ years in biotech/pharma with 6+ years in leadership, a strong regulatory background, and experience with INDs, CTAs, IMDPs, and post-approval submissions.