Director, Global Regulatory Strategy — Rare Disease

Regulatory Jobs; Bedford (MA); Híbrido; USD 248.000 - 280.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity participation

Medical, dental and vision insurance

401K plan with company match

Paid parental leave

Unlimited vacation time

Tuition assistance

Employee Stock Purchase Program (ESPP)

Descripción de la vacante

Stoke Therapeutics in Bedford, MA is seeking a Director of Global Regulatory Strategy to lead regulatory planning across programs and ensure compliance with health authority requirements in line with our corporate strategy.

This hybrid role will support early and late-stage development, manage regulatory submissions, and partner with cross-functional teams. The position is based in Bedford and will relocate to Waltham, MA by end of 2026, with about 10% travel.

Formación

• 8+ years of Regulatory Affairs experience in the pharmaceutical industry.
• BS, MS or Ph.D. in a scientific discipline preferred.
• Experience in rare disease drug development preferred and neurology indications ideal.
• Experience in major regulatory submissions and amendments/supplements and interfacing with authorities.
• Excellent verbal, written, negotiation, and interpersonal skills.
• Analytical thinker with problem-solving and deadline management.
• Ability to manage senior personnel and coordinate cross-functional teams.
• Well organized, self-motivated, detail oriented, and clear communicator.

Responsabilidades

• Defines and drives regulatory strategy for assigned activities/programs.
• Represents RA in internal teams to align regulatory plans with business objectives.
• Anticipates regulatory risks and design mitigation strategies.
• Primary contact for FDA and other regulatory agencies as needed.
• Plans and executes regulatory agency meetings and interactions.
• Oversee preparation and submission of global regulatory submissions.
• Contributes to continuous improvement of processes and SOPs.
• Identifies and monitors regulatory and policy issues.
• Develops regulatory knowledge and guides staff; updates policies accordingly.

Conocimientos

Regulatory strategy

FDA interactions

Cross-functional leadership

Regulatory submissions

Negotiation

Problem solving

Project management

Communication skills

Educación

BS/MS/PhD in scientific discipline

Descripción del empleo

Stoke Therapeutics in Bedford, MA is seeking a Director of Global Regulatory Strategy to lead regulatory planning across programs and ensure compliance with health authority requirements in line with our corporate strategy.

This hybrid role will support early and late-stage development, manage regulatory submissions, and partner with cross-functional teams. The position is based in Bedford and will relocate to Waltham, MA by end of 2026, with about 10% travel.