Director, Global Regulatory Affairs

Stoke Therapeutics•Bedford, MA

19h•$248,000 - $280,000•Hybrid

About The Position

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/ 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.

Requirements

8+ years minimum of Regulatory Affairs experience in the pharmaceutical industry.
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.

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.