Director, Regulatory CMC

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.25 Charlestown-HQ, Charlestown, MA, US

Salary Range: $ To $ Annually

Director, Regulatory CMC – Solid Biosciences

Charlestown, MA

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.

Regulatory CMC sits at the interface of the regulatory and technical operations organizations and provides leadership on CMC submission content and regulatory compliance. At Solid, regulatory CMC is a respected partner with Technical Operations and contributes from both a technical and regulatory perspective. We are seeking a highly experienced Director, Regulatory CMC to grow our team in support of Solid Biosciences' portfolio of rare disease genetic medicine programs.

This individual will serve as a key business partner to Technical Operations and Quality, as well as interactions with Program Leadership and Executive Management, to advance programs through late-stage development, registration, and commercialization.

The Director will be accountable for developing and executing global Regulatory CMC strategies for the AAV gene therapy portfolio that support increasingly complex manufacturing organizations, regulatory submissions, and post-approval lifecycle management activities. This role will play a critical part in manufacturing and geographical expansion, in addition to ensuring organizational readiness for future commercial marketing application submissions, and global health authority engagement.

The ideal candidate will bring deep Regulatory CMC expertise supporting biological products, including advanced therapies. Experience supporting biological products is a requirement and experience in AAV gene therapy products is strongly preferred.

Key Position Responsibilities

Regulatory CMC Strategy

• Develop, lead and execute comprehensive global Regulatory CMC strategies across Solid's clinical and late-stage development portfolio.
• Serve as the primary Regulatory CMC representative on cross-functional governance and development teams.
• Drive regulatory plans supporting pivotal development, registration-enabling activities, and lifecycle management.
• Assess evolving global regulatory expectations and translate regulatory intelligence into actionable program strategies.
• Provide strategic leadership regarding manufacturing changes, comparability approaches, control strategies, process validation, analytical method evolution, and product lifecycle planning.

Registration Readiness and Expansion

• Lead Regulatory CMC planning and execution for marketing authorizations and future geographical expansion.
• Establish regulatory strategies supporting phase-appropriate control systems, validation plans, potency methodologies, and commercial specifications.
• Lead development of integrated submission strategies that support development and commercialization objectives.

Global Health Authority Leadership

• Serve as the Regulatory CMC lead for FDA, EMA, MHRA, PMDA, Health Canada and other global agency interactions.
• Lead preparation of CMC briefing packages, responses, meeting materials, and negotiation strategies.
• Provide executive-level guidance regarding regulatory risks, agency feedback, and evolving expectations for advanced therapies and genetic medicines.
• Represent Solid as a credible scientific and regulatory expert during agency meetings and industry forums.

Commercial Manufacturing & Lifecycle Management

• Provide strategic oversight of regulatory activities supporting manufacturing network expansion, technology transfer, process changes, and lifecycle management initiatives.
• Guide regulatory assessments of manufacturing changes, comparability data, process performance qualification activities, and commercial supply…