Regulatory Affairs Director

6 days ago


Waltham, Massachusetts, United States Dyne Therapeutics Full time
Job Summary

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.

Key Responsibilities
  • Lead CMC regulatory execution for specific programs at all stages of development
  • Provide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirements
  • Develop and implement regulatory strategies for CMC-related projects and programs
  • Coordinate and manage global submissions, maintenance of product compliance, and management of change control related activities
  • Leverage technical and regulatory knowledge to mitigate risks and ensure compliance with regulatory requirements
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 preferred
  • Experience in Rare Disease preferred
  • Understanding of FDA regulatory guidance, ICH guidelines, and CTD format
About Dyne Therapeutics

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.

We are committed to developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue.

Our pipeline includes clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

We are an equal opportunity employer and welcome applications from diverse candidates.



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