Director, Regulatory Affairs CMC

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

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.

Primary Responsibilities Include:

• 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

Education and Skills Requirements:

• Bachelor’s degree in Life Sciences or a related scientific discipline required; advanced degree (MS/PhD) preferred
• 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
• Experience with EU and international regulatory requirements for both clinical and commercial programs is preferred
• 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
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