Director, Regulatory CMC

Role Summary

The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of development, through and beyond product approval. This role plays a critical leadership role in enabling clinical registration, commercial readiness, and manufacturing lifecycle management by ensuring high-quality, compliant, and strategically aligned CMC regulatory submissions worldwide.

Primary Responsibilities

• Lead and execute global CMC regulatory strategies for assigned programs across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle management

• Provide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance and readiness for clinical and commercial supply

• Oversee the planning, development, and delivery of high-quality CMC sections for global regulatory submissions and responses to Health Authority questions, including clinical and commercial manufacturing changes

• Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycle

• Act as the primary CMC Regulatory Affairs point of contact for cross-functional teams, providing clear direction on global regulatory requirements, timelines, and risks

• Represent Regulatory CMC in program, functional, and governance meetings, influencing decision-making without direct authority

Education And Skills Requirements

• Bachelor’s degree in life sciences or a related scientific discipline required; advanced degree preferred

• 10+ years of experience in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs, including significant CMC regulatory experience in clinical-stage and/or commercial biotechnology companies

• Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferred

• Experience in rare disease drug development preferred

• Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements

• Experience with EU and international regulatory frameworks related to clinical and commercial development is a plus

• Deep understanding of the drug development process, accelerated regulatory pathways, and evolving global regulatory policy trends

• Extensive experience with CTD structure, content, and global submission requirements

• Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment

• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations

• Exceptional written and verbal communication skills, including regulatory writing and executive-level communication

• Demonstrated ability to influence cross-functional stakeholders and senior leaders without direct authority

• Meticulous attention to detail with a commitment to quality and compliance

• Possess a positive, proactive, and resilient attitude

• Embody Dyne’s Core Values

• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases

• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities

• Embrace Dyne’s core values and culture

Pay Range

$196,000—$240,000 USD