Director, Global Regulatory Affairs
Stoke Therapeutics
Summary
The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke's portfolio. This role will provide regulatory leadership for various activities related to the development of Stoke programs and report to the Executive Director, Global Regulatory Strategy.
Job description
Position Purpose
The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke's portfolio. This role will provide regulatory leadership for various activities related to the development of Stoke programs and report to the Executive Director, Global Regulatory Strategy.
Key Responsibilities
- Defines and drives regulatory strategy for assigned activities/programs.
- Represents RA in various internal teams to align regulatory plans with business objectives and development timelines.
- Anticipates regulatory risks and design mitigation strategies. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
- Serves as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
- Plans and executes successful regulatory agency meetings and interactions per regulatory strategy.
- Oversee preparation and submission of global regulatory submissions to support program development, registration and maintenance activities.
- Contributes to the continuous improvement of existing processes and strategies, providing recommendations in their area of expertise.
- Identifies and monitors regulatory and policy issues.
- Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
Required Skills & Experience
- 8+ years minimum of Regulatory Affairs experience in the pharmaceutical industry.
- BS., M.S. or Ph.D. in a scientific discipline preferred
- Experience in rare disease drug development preferred and neurology indications ideal.
- Experience in the preparation of major regulatory submissions and supportive amendments or supplements for programs, including both early phase and late phase aspects of the project; direct experience in interfacing with relevant regulatory authorities.
- Excellent verbal, written, negotiation, and interpersonal skills.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Strong interpersonal skills and proven ability to effectively manage a variety of senior personnel including medical, scientific, and manufacturing staff.
- Well organized, self-motivated hard worker, smart independent thinker, demonstrated ability to work well under pressure and deadlines, detail oriented, with effective written and oral communication skills.
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 10% travel.
Requirements
- 8+ years minimum of Regulatory Affairs experience in the pharmaceutical industry.
- BS., M.S. or Ph.D. in a scientific discipline preferred
- Experience in rare disease drug development preferred and neurology indications ideal.
- Experience in the preparation of major regulatory submissions and supportive amendments or supplements for programs, including both early phase and late phase aspects of the project; direct experience in interfacing with relevant regulatory authorities.
- Excellent verbal, written, negotiation, and interpersonal skills.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Strong interpersonal skills and proven ability to effectively manage a variety of senior personnel including medical, scientific, and manufacturing staff.
- Well organized, self-motivated hard worker, smart independent thinker, demonstrated ability to work well under pressure and deadlines, detail oriented, with effective written and oral communication skills.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Long-term Disability Insurance
- Short-term Disability Insurance
- Paid Parental Leave
- 401(k) Matching
- Unlimited PTO
- Tuition Assistance
- Employee Stock Purchase Program
- Annual Bonus
- Equity Participation
Company overview
Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to developing novel RNA-based medicines for severe genetic diseases. Founded in 2014 and headquartered in Bedford, Massachusetts, the company employs its proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach to create antisense oligonucleotides (ASOs) that selectively restore naturally-occurring protein levels. Stoke's innovative platform focuses on haploinsufficiency diseases where patients have approximately 50% of normal protein levels, primarily targeting conditions affecting the central nervous system and eyes. The company's lead investigational medicine, zorevunersen (STK-001), is currently in Phase 3 clinical trials for Dravet syndrome, a severe form of childhood epilepsy, and has demonstrated promising disease-modifying potential. Stoke also has preclinical programs including STK-002 for autosomal dominant optic atrophy. The company has established strategic collaborations with industry leaders like Biogen for Dravet syndrome development and Acadia Pharmaceuticals for neurodevelopmental disorders. With approximately 51-200 employees, Stoke Therapeutics represents a pioneering force in RNA medicine, aiming to address unmet medical needs in rare genetic diseases through its innovative protein restoration technology.