Director, Regulatory CMC

Описание вакансии

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. 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. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

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.

The Director serves as a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk assessment, and leadership across early- and late-stage programs. This role operates with a high degree of independence and influence, contributing to program-level decision-making and organizational regulatory excellence.

This role is based in Waltham, MA.

Primary Responsibilities Include:

Strategic Leadership & Program Ownership

• 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
• Serve as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization objectives
• Provide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance and readiness for clinical and commercial supply

Regulatory Submissions & Health Authority Engagement

• 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
• Ensure alignment of CMC regulatory content with evolving regulatory expectations, guidance, and policy trends across regions
• Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycle

Cross-Functional Leadership & Influence

• 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
• Partner closely with Manufacturing, Quality, Clinical Operations, and Program Management to deliver critical regulatory milestones

Operational Excellence & Knowledge Leadership

• Drive execution of regulatory policies, processes, and best practices to ensure consistent, compliant, and efficient regulatory operations
• Leverage deep technical and regulatory expertise to anticipate challenges and enable proactive problem-solving
• Mentor and support the development of regulatory team members, fostering a culture of collaboration, accountability, and continuous learning
• Contribute to the advancement of Dyne’s regulatory capabilities by sharing knowledge, lessons learned, and regulatory insights across the organization

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
• Highly collaborative leader and team player with a strong cross-functional mindset
• Meticulous attention to detail with a commitment to quality and compliance
• Positive, proactive, and resilient leader who embodies 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

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MA Pay Range

$196,000—$240,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.