Stoke Therapeutics is looking for Vice President of Regulatory Affairs to develop and implement a regulatory strategy working closely with cross-functional teams to summarize scientific data and submission packages to US and regulatory agencies. This position, which reports to the Chief Medical Officer, requires a candidate with a deep knowledge and understanding of the global regulatory environment and a passion for patients with debilitating neurological diseases.
Filing and supervising submission of multiple INDs and determining the strategy for multiple projects.
Actively leading the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks and pathways for expedited development and timelines
Serving as the regulatory representative on project teams
Active involvement in writing/review of regulatory submissions
Interfacing with Health authorities
Coordinating all aspects of regulatory submissions
Proactively keeping updated on regulatory requirements and expedited approaches worldwide
Hiring, building, supervising and managing a team of regulatory professionals who will support Stoke’s efforts in multiple therapeutics areas
Master’s Degree is required, PharmD, PhD or MD degree is preferred.
At least 10 years of experience working in Regulatory Affairs; ideally in the biotech industry. Experience in rare diseases, oligonucletotides or neurology is required.
Sound knowledge and experience in Regulatory Affairs and associated requirements, plus pharmaceutical industry experience in clinical trial and drug development work with a record of successful drug development through product approval in the US, EU, Asia.
Thorough knowledge of the drug development process including all expedited pathways and orphan drug designations, INDs, CTAs, NDAs and MAAs.
Experience in interfacing directly with FDA and other Health authorities.
This position will be required to go to both Bedford, MA and Cambridge, MA offices
Internal Number: VPRA
About Stoke Therapeutics
Stoke is developing antisense oligonucleotide medicines that target RNA splicing to increase gene expression for the treatment of severe genetic diseases.