Regulatory Affairs Director

1 week ago

Waltham, Massachusetts, United States Dyne Therapeutics Full time
Job Title: Associate Director, Regulatory CMC

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) plays a pivotal role in executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and manufacturing efforts, as applicable. The Associate Director partners with the manufacturing team, clinical operations, quality, other regulatory team members, and program teams to drive regulatory excellence.

This role is based in Waltham, MA, and requires collaboration with cross-functional teams to meet critical regulatory milestones.

Key Responsibilities:
  • Lead CMC regulatory execution for specific programs at all stages of development, ensuring compliance with global regulatory requirements.
  • Provide strategic Regulatory input to the Manufacturing and Quality organizations, guiding global product development requirements.
  • Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
  • Lead the development of CMC documentation for global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests, collaborating with Manufacturing and Quality team members.
  • Coordinate and manage global submissions, maintain product compliance, and manage change control related activities.
  • Leverage technical and regulatory knowledge to mitigate risks and ensure regulatory compliance.
  • Represent the Regulatory Affairs CMC team in functional meetings and serve as the point of contact for cross-functional teams on global Regulatory CMC project/program issues.
  • Execute regulatory policies and operational processes, delivering high-quality regulatory submissions.
  • Act as the company liaison on CMC Regulatory matters, supporting related meetings, including preparation of briefing books, training, and preparing the technical team.
Requirements:
  • Minimum of a bachelor's degree in life science or related discipline.
  • Minimum of 7 years of experience in the biotech/pharmaceutical industry with a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company.
  • Experience leading and developing CMC sections of marketing applications is preferred.
  • Experience in Rare Disease is preferred.
  • Understanding of FDA regulatory guidance, ICH guidelines, and CTD format and content of regulatory filings.
  • Strong experience with biologics and thorough understanding of drug development process and pharmaceutical industry requirements.
  • Ability to work independently to manage multiple projects in a fast-paced environment and effectively collaborate in a dynamic, cross-functional environment.
  • Outstanding communication skills, regulatory writing skills, and willingness to share knowledge and lessons learned with strong attention to detail.
  • Ability to interact effectively and influence across relevant functions within Dyne and with regulators.
  • Recognized as a leader, team player, and possess a cross-functional collaborative skill set.
  • Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities.
  • Embrace Dyne's core values and culture.
  • Excitement about the vision and mission of Dyne.

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