Dyne Therapeutics
Associate Director, Regulatory CMC
Waltham, MA · Director
Sponsorship not specifiedDetected 21 days ago
FDA RegulatoryAnimal StudiesLeadershipRegulatory Affairs
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- Lead CMC Regulatory execution for specific programs at all stages of development
- Serve as a CMC strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with input and guidance from the team and leadership
- Execute regulatory policies and operational processes to deliver high quality regulatory submissions
Requirements
- Minimum of a bachelor's degree in life science or related discipline is required
- Minimum of 7 years of experience in the biotech/pharmaceutical industry, and a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company
- Strong experience with CTD format and content of regulatory filings
Nice to have
- Experience in Rare Disease preferred
- Knowledge of EU and international regulations related to clinical and nonclinical, development a plus
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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