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Senior Director, Regulatory Affairs

Waltham, MA

Senior Director, Regulatory Affairs

The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for small molecule programs across early and late-stage development to support global regulatory approvals. This role serves as the primary regulatory lead for assigned programs and represents Regulatory Affairs on core program teams. The position reports to the SVP of Clinical Development.

Responsibilities:

  • Lead the planning, design, and implementation of clinical, nonclinical, and CMC regulatory strategy—including preparation, submission, and maintenance of regulatory applications—in a phase-appropriate manner across global markets.
  • Independently manage the development of high-quality regulatory documents, including direct authoring and/or reviewing of IND/IMPD/CTA submissions, meeting requests and briefing documents, and responses to regulatory requests for information, while adhering to timelines, company standards, and industry guidelines.
  • Serve as primary regulatory contact with Health Authorities, including leading agency meetings, managing meeting requests, and coordinating responses to requests for information across major markets (FDA, EMA, and others).
  • Serve as lead Regulatory Affairs representative on cross-functional program teams; provide guidance to and oversight of internal and external resources to ensure compliance with applicable, phase-appropriate regulatory standards, guidelines, and protocols.
  • Provide regulatory input for risk assessments pertaining to the quality, safety, and efficacy aspects of programs and applications; think critically and strategically to evaluate and communicate regulatory risk.
  • Lead at least one global regulatory approval end-to-end, including management of the response team and labeling negotiations.
  • Keep current on changes in regulatory legislation, guidelines, and precedents from competitor products, prior approvals, and relevant external programs; integrate global regulatory intelligence into program strategy.
  • Contribute to non-project business initiatives at the portfolio or cross-functional level as needed.

Education/Skills/Experience Requirements:

  • Bachelor's degree in a science-related field with 10+ years of demonstrated experience in a pharmaceutical/biotechnology environment, including 5+ years in Regulatory Affairs; or an advanced degree with 7–10 years of relevant experience.
  • CNS drug development is a plus.
  • Demonstrated success developing and executing regulatory strategy for small molecule drug programs.
  • Proven experience leading Health Authority interactions in major markets (FDA, EMA).
  • Proven leadership of regulatory and cross-functional teams, including stakeholder management across matrixed organizations.
  • Experience in due diligence activities and business alliance or partnership environments.
  • Experience with Veeva Vault or comparable regulatory information management systems.
  • Broad background across multiple areas of regulatory affairs and overall drug development processes.
  • Excellent written, verbal, and presentation communication skills.
  • Strong organizational and project management skills; self-motivated with the ability to manage multiple programs and adapt to shifting priorities in a fast-paced environment.

Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Senior Director, Regulatory Affairs is $270,000-350,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.

About Skyhawk

Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.

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