Senior Manager, Regulatory Affairs, CMC

Stoke Therapeutics; Bedford (MA); Hybrid; USD 181,000 - 213,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical, dental and vision insurance

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies, lifecycle management, and cross-functional guidance across programs. Reports to the Director of Regulatory CMC.

The role focuses on leading CMC regulatory strategies for development and potential commercialization, with emphasis on Module 3, health authority engagement, and global submissions. Location is hybrid/remote in Bedford, MA, with a move to Waltham; travel minimal; salary range

Qualifications

• 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 regulatory experience; Working in complex and matrix environments; Oligonucleotide drug development

Responsibilities

• Prepares and executes global regulatory CMC strategy for development programs, including new applications, amendments, annual reports, supplements and responses to health authority questions
• Lead author, and collaborate with SMEs, for Quality Modules; 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 processes to track regulatory dossier lifecycle management, health authority questions, and post-approval commitments
• Develops and implements documents, policies, and procedures for regulatory operational alignment and efficiencies
• Builds and maintains relationships within Regulatory Affairs and Technical Operations (CMC) teams
• Location: Stoke is in Bedford, MA; hybrid/remote; moving to Waltham; travel minimal

Skills

Regulatory strategy development

CMC regulatory affairs

US & EU regulatory experience

Health authority engagement

Veeva RIM

Quality Modules

Regulatory lifecycle management

Technical writing

Cross-functional collaboration

Communication skills

Education

BS/BA in science/engineering

Advanced degree preferred

Tools

Veeva RIM

MS Office

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 in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

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 in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

The Regulatory CMC Senior 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, or remote, 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 $181,000 - $213,000. 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.