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CMC Regulatory Affairs Expert
2 months ago
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.
- 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.
- Strong experience with global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends.
- 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.
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue.
