Associate Director, Global Regulatory Strategy

Stoke Therapeutics, Inc.•Bedford, MA

40d•$189,000 - $227,000•Hybrid

About The Position

The Associate Director of Regulatory Strategy supports the development and implementation of innovative global regulatory strategies for preclinical and early clinical development products, as assigned. This role will be responsible for collaborating across teams to provide regulatory guidance and manage regulatory submissions to meet corporate goals. Serves as a liason between internal teams and external partners to communicate regulatory plans and updates, navigate complex regulatory issues and ensure alignment across program teams/subteams. This position reports to the Executive Director, Regulatory Affairs.

Requirements

Bachelor's degree in health sciences or related field; an advanced degree is preferred.
Minimum of 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs.
Prior experience in regulatory strategy supporting global clinical trials.
Ability to assess and understand complex scientific information, regulatory precedents, competitive intelligence, and regulatory guidelines and make recommendations based on assessment.
Excellent verbal, written, negotiation, and interpersonal skills.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Proven ability to carry out complex projects, with flexibility and adaptability.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Nice To Haves

Experience in rare disease drug development is highly desirable.

Responsibilities

Support the development and implementation of global regulatory strategies for assigned programs, ensuring alignment with corporate objectives and regulatory requirements.
Lead or support the development of high-quality regulatory documents, including authoring and/or reviewing documents for IND/CTA submissions, heath authority meetings, regulatory applications (orphan, BTD, etc) and responses to health authority requests for information.
Contribute to the planning and execution of successful regulatory agency meetings and interactions; may independently lead regulatory communication and interactions with the health authority.
Represent Regulatory on clinical study teams, cross-functional development subteams, and program teams as assigned to provide strategic regulatory guidance and support to achieve product development goals.
Contribute to the development of risk assessments pertaining to the execution, quality, safety, and efficacy aspects of programs and applications.
Collaborate with internal and external stakeholders, manage and oversee third-party vendors and consultants to ensure high-quality submissions and successful execution of clinical trials and regulatory strategies.
Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs.
Lead or contribute to process improvement or operational excellence initiatives within Regulatory function or Stoke in general, as applicable.
Stay current with evolving regulatory requirements and best practices, and ensure compliance with all applicable regulations, guidelines, and industry standards.