New · posted Oct 15
Stoke Therapeutics · Biotechnology
Vice President, Regulatory Strategy and CMC
- Bedford, MA
- Hybrid
- Full-time
- VP & Executive
Open until filled
The role
The Vice President, Regulatory Strategy & CMC is responsible for leading teams to develop and execute global regulatory and Chemistry, Manufacturing & Controls (CMC) strategies across the company's product portfolio. This leader provides strategic direction for regulatory interactions, product development, manufacturing, quality, and commercialization activities to support clinical development, regulatory approvals, and lifecycle management.
The VP will lead cross-functional collaboration across Regulatory Affairs, Technical Operations, CMC , Quality, Clinical Development, Supply Chain, and external partners to ensure successful advancement of programs from early development through commercialization. The role serves as the primary executive advisor on regulatory and CMC risks, opportunities, and policy considerations impacting corporate strategy.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
What you need
Required Skills & Experience
- Ph.D., Pharm.D., M.S., or advanced scientific degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Biotechnology, or related discipline preferred.
- 12+ years of progressive experience in biotechnology, pharmaceutical, or cell and gene therapy industries, with at least 6 years in a leadership capacity.
- Deep expertise in global Regulatory Affairs and CMC development.
- Demonstrated success leading major regulatory submissions and health authority interactions.
- Experience advancing products from early development through commercialization.
- Significant experience managing multiple development programs.
- Proven executive leadership experience building and managing multidisciplinary teams.
Critical Competencies
- Executive presence and ELT-level communication
- Risk assessment and decision-making
- Cross-functional influence and collaboration
- Change management and organizational leadership
- Negotiation and stakeholder management
- Financial and operational planning
What you'll do
Regulatory Strategy Leadership
- Provide oversight and guidance into development and implementation of integrated global regulatory strategies for Stoke programs.
- Lead and manage teams responsible for INDs, CTAs, IMPDs, BLAs, NDAs, MAAs, and post-approval submissions.
- Serve as the executive lead for interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies.
- Provide strategic regulatory guidance to executive leadership and program teams regarding development pathways, agency expectations, accelerated programs, and risk mitigation.
- Monitor evolving regulatory requirements and assess impacts on development and commercial programs.
- Support corporate business development, licensing, due diligence, and portfolio evaluation activities.
CMC Strategy & Technical Operations
- Provide oversight and guidance into enterprise-wide CMC strategies for drug substance, drug product, analytical development, process development, manufacturing, supply, and combination drug-device development.
- Ensure phase-appropriate CMC development plans are aligned with regulatory expectations and business objectives.
- Lead and manage teams responsible for CMC readiness activities supporting clinical studies, registration, launch, and lifecycle management.
- Partner with Quality and Technical Operations to ensure compliance with cGMP, ICH, FDA, EMA, and global regulatory requirements.
- Provide strategic regulatory guidance on long-range manufacturing and supply strategies to support global commercial expansion.
Organizational Leadership
- Build, mentor, and lead high-performing Regulatory Strategy and CMC teams.
- Establish department goals, governance processes, resource planning, and budget management.
- Foster a collaborative, science-driven, and compliance-focused culture.
- Influence company strategy through participation on executive leadership committees and governance boards.
- Manage external consultants, CROs, CDMOs, and strategic partnerships supporting regulatory and manufacturing activities.
Commercialization & Lifecycle Management
- Support launch readiness activities and commercial regulatory strategies.
- Oversee post-approval changes, global lifecycle management activities, and market expansion initiatives.
- Ensure regulatory compliance throughout the product lifecycle while enabling operational flexibility and business growth.
- Identify regulatory and manufacturing risks and develop proactive mitigation strategies.
Pay and benefits
$345,000 – $395,000 a year
Employer providedAt Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
The anticipated salary range for this role is $345,000 - $395,000. 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).
Medical, dental and vision insurance
Annual bonus and equity
401(k) with company match
Unlimited vacation
Paid parental leave
Employee Stock Purchase Plan
Where you'll work
Bedford, MAHybridOpen in Maps (opens in a new tab)
More jobs in Bedford, MAWorking conditions
Travel
This position will require approximately 10% travel.
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.
From the posting
About Stoke Therapeutics
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/
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.
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/.
Equal opportunity, accessibility and legal noticesStoke Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $345,000 | — | $395,000 |
This role: Stoke Therapeutics's own published range.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Stoke Therapeutics's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Regulatory submissions5
- GMP and compliance3
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Stoke Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 1
- Locations
By discipline
- Regulatory3 75%
- Quality1 25%
By level
- Director2 50%
- VP & Executive1 25%
- Manager1 25%
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Vice President, Regulatory Strategy and CMC at Stoke Therapeutics
Open until filled. $345K–$395K a year, employer provided.