Regulatory CMC Manager — Global Strategy & Lifecycle (Remote)

Stoke Therapeutics; Bedford (MA); Hybrid; USD 145,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical, dental, vision insurance

401K with company match

Unlimited vacation time

Parental leave

Job summary

Stoke Therapeutics is seeking a Regulatory CMC Manager to drive global regulatory CMC strategies across multiple programs. You will collaborate with cross-functional teams including Regulatory Affairs and Technical Operations to navigate FDA/EMA requirements.

The role requires a strong background in Module 3, experience with post-approval CMC activities, and a track record of delivering regulatory milestones in a complex, matrix environment.

Qualifications

• BS/ BA in scientific, pharmaceutical or engineering discipline; advanced degree preferred.
• Minimum of 8 years industry experience, including at least 5 years in CMC Regulatory Affairs.
• Experience developing regulatory strategies in US and EU markets.
• Experience with commercial phase programs and post-approval CMC requirements.
• Deep understanding of Module 3 ICH/FDA/EMA regulations.

Responsibilities

• Lead global regulatory CMC strategy for development and future commercial programs.
• Author and coordinate Quality Modules with SMEs; manage document review workflows.
• Analyze technical information for regulatory strategy impact.
• Assess change controls for regulatory impact and implement compliance.
• Develop lifecycle management processes for dossier/regulatory commitments.

Skills

Regulatory strategy

US & EU regulatory

Oral and written comms

Cross-functional collaboration

Regulatory milestones

Education

Scientific/engineering degree

Tools

Veeva RIM

Job description

Stoke Therapeutics is seeking a Regulatory CMC Manager to drive global regulatory CMC strategies across multiple programs. You will collaborate with cross-functional teams including Regulatory Affairs and Technical Operations to navigate FDA/EMA requirements.

The role requires a strong background in Module 3, experience with post-approval CMC activities, and a track record of delivering regulatory milestones in a complex, matrix environment.