Regulatory Chemistry Manufacturing and Control Director

3 hours ago


Waltham, Massachusetts, United States Dyne Therapeutics Inc Full time
Job Title: Associate Director, Regulatory Chemistry Manufacturing and Control

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics Inc, 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, 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, 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, with authoring support from 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.
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 is required.
  • Strong experience with biologics and global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends is preferred.
  • Knowledge of EU and international regulations related to clinical and nonclinical development is a plus.

Dyne Therapeutics Inc is a dynamic and innovative company, and we are seeking a highly skilled and experienced professional to join our team as an Associate Director, Regulatory Chemistry Manufacturing and Control. If you are a motivated and results-driven individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.



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