Regulatory CMC Manager: Global Strategy & Lifecycle

Regulatory Jobs; Bedford (MA); Híbrido; USD 145.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity participation

Medical, dental, and vision insurance

401K with company match

Unlimited vacation time

Tuition assistance

ESPP

Descripción de la vacante

Stoke Therapeutics, headquartered in Bedford, MA, seeks a Regulatory CMC Manager to shape global regulatory CMC strategy across programs, reporting to the Director of Regulatory CMC. The role is hybrid, located in Bedford/Waltham, MA, with responsibilities spanning US/EU markets and post-approval activities.

You will lead Quality Modules, interact with health authorities, and drive lifecycle management while collaborating with cross-functional teams to ensure regulatory success.

Formación

• BS/BA in scientific, pharmaceutical or engineering discipline; advanced degree preferred.
• Minimum of 8 years of industry experience, including 5+ years in CMC Regulatory Affairs.
• Direct experience in US and EU regulatory strategies for development and post-approval programs.
• Experience authoring Quality Modules 2.3/3; engagement content for health authorities.

Responsabilidades

• Prepares and executes global regulatory CMC strategy for development and future commercial programs.
• Lead author for Quality Modules and manage document review workflows.
• Analyze technical information for regulatory impact and strategic decisions.
• Assess change controls for regulatory impact and manage compliance systems.
• Develops lifecycle management processes, health authority Qs, and post-approval commitments.
• Implements documents/policies for regulatory operation alignment and efficiencies.
• Builds relationships within Regulatory Affairs and Technical Operations teams.

Conocimientos

CMC regulatory strategy

US/EU regulatory experience

Regulatory strategy writing

Cross-functional collaboration

Strong written/verbal communication

Educación

BS/BA in scientific or engineering discipline

Advanced degree preferred

Herramientas

Veeva RIM

Descripción del empleo

Stoke Therapeutics, headquartered in Bedford, MA, seeks a Regulatory CMC Manager to shape global regulatory CMC strategy across programs, reporting to the Director of Regulatory CMC. The role is hybrid, located in Bedford/Waltham, MA, with responsibilities spanning US/EU markets and post-approval activities.

You will lead Quality Modules, interact with health authorities, and drive lifecycle management while collaborating with cross-functional teams to ensure regulatory success.