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Regulatory Chemistry Manufacturing and Control Strategist

2 months ago

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

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, 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 for projects/programs, providing regulatory assessments and developing regulatory strategies.
  • Lead the development of CMC documentation for global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests.
  • 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.
  • Serve as the Regulatory Affairs CMC representative in functional meetings and act as a 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, and preparing briefing books, training, and technical teams.
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 and content of regulatory filings.
  • Thorough understanding of drug development process and the pharmaceutical industry, including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends.
  • Knowledge of EU and international regulations related to clinical and nonclinical development a plus.
  • Ability to work independently to manage multiple projects in a fast-paced environment.
  • Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program's critical regulatory milestones.
  • Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management.
  • Outstanding communication skills (verbal and written), 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.