Associate Director, Regulatory CMC

Responsibilities

• Lead CMC Regulatory execution for specific programs at all stages of development
• Provide strategic Regulatory input to the Manufacturing and Quality organizations
• Serve as a CMC strategist and project leader for regulatory assessments and strategies
• Lead the development of CMC documentation for global Regulatory filings (IND, IMPD, BLA, etc.)
• Coordinate and manage global submissions, product compliance, and change control activities
• Act as the Regulatory Affairs CMC representative in functional and team meetings
• Mitigate risks using technical and regulatory knowledge
• Communicate regulatory strategy, risks, and plans to senior management

Requirements

• Bachelor’s degree in life science or related discipline
• Minimum of 7 years of experience in the biotech/pharmaceutical industry
• Minimum of 5 years in regulatory affairs in a clinical-stage or commercial biotechnology company
• Solid understanding of FDA regulatory guidance and ICH guidelines
• Strong experience with CTD format and regulatory filing content
• Thorough understanding of the drug development process and global regulatory CMC requirements
• Ability to work independently and manage multiple projects in a fast-paced environment

Preferred Qualifications

• Experience in Rare Disease
• Experience leading and developing CMC sections of Biologics marketing applications
• Knowledge of EU and international regulations related to clinical and nonclinical development

About the Company

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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.