Director, Regulatory Affairs CMC

ProPharma•Raleigh, NC

1d•Remote

About The Position

The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is a senior-level contractor role responsible for defining and executing global CMC regulatory strategies across Dyne’s development programs, from early-stage development through commercialization and post-approval lifecycle management. This individual will serve as a strategic leader and subject matter expert (SME), ensuring high-quality, compliant, and globally aligned CMC regulatory submissions. The role will partner closely with Manufacturing, Quality, Clinical Operations, and Program Teams to support clinical registration, commercial readiness, and ongoing regulatory compliance. The position requires a highly experienced regulatory professional capable of operating independently, influencing cross-functional stakeholders, and driving complex regulatory strategies while meeting critical timelines in a fast-paced, dynamic biotech environment.

Requirements

Bachelor’s degree in Life Sciences or a related scientific discipline required
Minimum of 10+ years of experience in biotechnology or pharmaceutical industry, including at least 7+ years in Regulatory Affairs with strong focus on CMC
Demonstrated experience leading CMC sections of global regulatory submissions, including biologics marketing applications (BLA/MAA)
Strong experience supporting global regulatory filings and health authority interactions (e.g., FDA, EMA, and other international agencies)
Deep understanding of CMC regulatory requirements across clinical development, commercialization, and lifecycle management
Strong working knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks
Extensive experience with CTD structure, content, and global submission requirements
Proven ability to independently manage multiple complex regulatory programs in a fast-paced environment
Strong strategic thinking and problem-solving skills, with the ability to balance scientific, operational, and regulatory considerations
Excellent written and verbal communication skills, including regulatory writing and executive-level communication
Demonstrated ability to influence cross-functional stakeholders and senior leadership without direct authority
High level of attention to detail with strong commitment to quality and compliance
Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
Ability to work independently and operate in a highly autonomous manner with minimal oversight
Candidates must demonstrate recent, hands-on experience supporting CMC regulatory activities within regulated life sciences environments

Nice To Haves

advanced degree (MS/PhD) preferred
Experience with EU and international regulatory requirements for both clinical and commercial programs is preferred

Responsibilities

Lead and execute global CMC regulatory strategies across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle activities
Provide strategic regulatory guidance to Manufacturing and Quality teams to ensure global compliance and readiness for clinical and commercial supply
Oversee the planning, development, and delivery of CMC sections for global regulatory submissions, including responses to Health Authority (HA) questions
Manage regulatory activities related to clinical and commercial manufacturing changes, ensuring alignment with global requirements
Ensure CMC regulatory content aligns with evolving regulatory expectations, guidance, and policy trends across regions
Coordinate global submissions, product registration maintenance, and change control activities throughout the product lifecycle
Partner cross-functionally with Manufacturing, Quality, Clinical Operations, and Program Teams to deliver key regulatory milestones
Proactively identify regulatory risks and develop mitigation strategies to support program success
Leverage deep regulatory expertise to anticipate challenges and drive effective, forward-looking solutions
Contribute to organizational regulatory knowledge by sharing insights, lessons learned, and best practices