Director, Global Regulatory Affairs

Socket.dev; Bedford (MA); Hybrid; USD 248,000 - 280,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life, long- and short-term disability

Paid parental leave

401K plan with company match

Unlimited vacation time

Tuition assistance

ESPP

Job summary

Stoke Therapeutics seeks a Director, Global Regulatory Strategy to lead global regulatory planning across programs, reporting to the Executive Director, Global Regulatory Strategy. This hybrid role is based in Bedford, MA with future move to Waltham and ~10% travel.

Responsibilities include defining strategy, representing RA in cross-functional teams, managing FDA interactions, and preparing global submissions.

Qualifications

• 8+ years minimum of Regulatory Affairs experience in the pharmaceutical industry.
• S., M.S. or Ph.D. in a scientific discipline preferred
• Experience in rare disease drug development preferred and neurology indications ideal.
• Experience in preparation of major regulatory submissions and supportive amendments or supplements for programs; direct experience interfacing with 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 manage senior personnel including medical, scientific, and manufacturing staff.
• Well organized, self-motivated, detail oriented with effective written and oral communication skills.

Responsibilities

• Defines and drives regulatory strategy for assigned activities/programs.
• Represents RA in internal teams to align regulatory plans with business objectives and timelines.
• Anticipates regulatory risks and design mitigation strategies; educates stakeholders about risk.
• Serves as primary contact for assigned projects with the FDA and other regulatory agencies.
• Plans and executes regulatory agency meetings and interactions per strategy.
• Oversee preparation and submission of global regulatory submissions to support program development, registration and maintenance.
• Contributes to process and policy improvements and SOP implementations.
• Identifies and monitors regulatory and policy issues.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Risk management

Interpersonal skills

Education

PhD/MS in science

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/

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.
• S., 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.

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 $248,000 - $280,000. 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.

• 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
• 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.