Manager, Regulatory Affairs, CMC

Regulatory Toolkit; Bedford (MA); Hybrid; USD 145,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical, dental, and vision insurance

401K with company match

Unlimited vacation time

Tuition assistance

ESPP

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CMC regulatory strategy

US/EU regulatory experience

Regulatory strategy writing

Cross-functional collaboration

Strong written/verbal communication

Education

BS/BA in scientific or engineering discipline

Advanced degree preferred

Tools

Veeva RIM

Job description

About Stoke:

Stoke Therapeutics(Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered inBedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

The Regulatory CMC Manager is responsible for contributing to the development of Stoke’s products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. This position will report to the Director of Regulatory CMC.

Key Responsibilities:

• Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.
• Lead author, and able to collaborate with Subject Matter Experts, for Quality Modules. Effectively manage document review and approval workflows.
• Analyzes and interprets technical information for impact to regulatory strategy and decisions
• Assesses change controls for regulatory impact and manages the implementation system for regulatory compliance
• Develops process(es) to track regulatory dossier lifecycle management, health authority questions, and post approval commitments, as needed
• Develops and implements documents, policies, and/or procedures for regulatory operational alignment and efficiencies
• Builds and maintains relationships within the Regulatory Affairs department and Technical Operations (CMC) teams

Required Skills & Experience:

• BS/ BA degree in scientific, pharmaceutical or engineering discipline; advanced degree preferred
• Minimum of 8 years of industry experience, including a minimum of 5 years directly in CMC Regulatory Affairs
• Direct experience developing and implementing successful regulatory strategies in both US and EU markets
• Direct experience with commercial phase programs and post-approval CMC requirements and implementation of regulatory milestones (e.g., Annual Reports)
• Deep understanding of Module 3 sections and associated ICH, FDA, EMA regulations and guidance documents
• Experience authoring Quality Modules 2.3 and 3; and health authority engagement content (e.g., FDA Briefing Books)
• Practical experience in one of the following areas: manufacturing; process development; validation; analytical development, and/or quality.
• Understanding of technical operations functions and systems including, but not limited to, technical risk assessments, change controls
• Strong oral and written communication skills
• Direct experience with Veeva RIM required
• Preferred Experience:
  • Combination Product and/or device experience
  • Global (beyond US, EU) regulatory experience
  • Working in complex and matrix environments
  • Oligonucleotide drug development

Location(s):

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position, currently based in Bedford and will later be based in Waltham.

Travel:

This position will require approximately [0%] travel, unless remote then periodic travel to Bedford/ Waltham is expected.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $145,000 - $160,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.