The Director of Regulatory Affairs reports to the SVP, Regulatory Affairs & Quality and will be responsible for developing and delivering global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio. This role will provide regulatory support for various departments, projects, and teams.
- Leads the development and implementation of regulatory strategy and activities.
- Represents RA in product development project teams advising on timelines, regulations, process, and requirements.
- Serves as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
- Provides regulatory guidance from early stage (pre-IND/CTA) through commercialization
- Identifies and evaluates regulatory risks and establish risk mitigation.
- Plans and executes successful regulatory agency meetings and interactions per regulatory strategy.
- Develops and implements global regulatory strategies and plans.
- Initiates and plans health authority meetings with global regulatory agencies.
- Prepares and delivers effective presentations for external and internal audiences.
- 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 risk assessment plans. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
- 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:
- M.S. or Ph.D. in Life Sciences or related degree preferred.
- 7-8 years minimum of pharmaceutical/biotechnology industry experience in Regulatory Affairs lead role.
- Experience in rare disease drug development is highly desirable.
- Experience and comfort with a fast-paced biotech company environment
- International regulatory experience (US, EU and Japan) would be a plus.
- Knowledge and experience in interpretation of regulations, guidelines, and policy statements, etc.
- Experience in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs, including both clinical and pre-clinical aspects of the project; direct experience in interfacing with relevant regulatory authorities.
- Foster effective, positive interactions with regulatory agencies, and corporate partners.
- Demonstrate excellent leadership and communication skills
- Demonstrate strong organizational skills.
- Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
- Well organized, self-motivated handworker, smart independent thinker, works well under pressure and deadlines, detail oriented, effective written and oral communication skills.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.
Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.
Benefits & Compensation:
Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.