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Regulatory Affairs Director

2 months ago

Waltham, Massachusetts, United States Dyne Tx Full time
About Dyne Tx

Dyne Tx is a clinical-stage biotechnology company dedicated to developing innovative therapeutics for people living with genetically driven diseases.

Job Summary

We are seeking a highly experienced Regulatory Affairs Director to lead our CMC regulatory strategies for our programs in early and late-stage development. This role will support our clinical registration, commercial development, and manufacturing efforts, partnering with our manufacturing team, clinical operations, quality, and program teams.

Key Responsibilities
  • CMC Regulatory Execution: Lead the execution of global CMC regulatory strategies for specific programs at all stages of development.
  • Regulatory Input: Provide strategic regulatory input to our manufacturing and quality organizations on global product development requirements.
  • CMC Strategist: Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies.
  • Documentation Development: Lead the development of CMC documentation for global regulatory filings and responses to health authority requests.
  • Global Submissions: Coordinate and manage global submissions, maintain product compliance, and manage change control related activities.
  • Risk Mitigation: Leverage technical and regulatory knowledge to mitigate risks.
  • Regulatory Representation: Serve as the Regulatory Affairs CMC representative in functional meetings and act as a point of contact for cross-functional teams.
  • Regulatory Policies: Execute regulatory policies and operational processes, delivering high-quality regulatory submissions.
Requirements
  • Education: Minimum of a bachelor's degree in a life science or related discipline.
  • Experience: 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.
  • Skills: Strong experience with CTD format and content of regulatory filings, biologics experience preferred. Thorough understanding of FDA regulatory guidance, ICH guidelines, and global regulatory CMC requirements.
  • Leadership: Ability to work independently, manage multiple projects, and effectively collaborate in a dynamic, cross-functional environment.
  • Communication: Outstanding communication skills, regulatory writing skills, and willingness to share knowledge and lessons learned.