Director, Regulatory CMC

Solid Biosciences • Charlestown, MA

14h

About The Position

Solid Biosciences is a precision genetic medicine company developing gene therapy candidates for rare neuromuscular and cardiac diseases. The Director, Regulatory CMC will provide leadership on CMC submission content and regulatory compliance, partnering closely with Technical Operations and Quality, as well as Program Leadership and Executive Management. The role supports Solid’s rare disease genetic medicine portfolio as programs advance through late-stage development, registration, and commercialization.

The Director will develop and execute global Regulatory CMC strategies for the AAV gene therapy portfolio, supporting complex manufacturing organizations, regulatory submissions, and post-approval lifecycle management. This role will contribute to manufacturing and geographical expansion, organizational readiness for commercial marketing applications, and global health authority engagement.

The position requires deep Regulatory CMC expertise supporting biological products; direct experience with AAV gene therapy products is strongly preferred. The role is based in Charlestown, Massachusetts.

Requirements

• BS, MS, PhD, PharmD, or equivalent scientific degree.
• 12+ years of Regulatory Affairs experience with significant Regulatory CMC responsibility for biological products.
• Demonstrated success leading global Regulatory CMC strategy for biologics.
• Experience leading development objectives, including product characterization and process evolution.
• Experience supporting registration-enabling programs and marketing application submissions.
• Proven track record leading FDA or EMA health authority interactions.
• Strong understanding of GMP manufacturing, process validation, analytical development, comparability, quality systems, and commercial manufacturing requirements.
• Experience leading cross-functional teams in a fast-paced biotechnology environment.

Nice To Haves

• Direct experience supporting AAV gene therapy products.
• Experience with EU development strategies, including scientific advice and commercial readiness.
• Experience with BLA preparation, regulatory review, and post-approval lifecycle management.
• Experience supporting programs in Duchenne muscular dystrophy (DMD), Friedreich’s ataxia (FA), or genetic diseases.
• Experience with potency assay development, vector characterization, comparability, and commercial manufacturing strategies for gene therapies.
• Experience supporting pre-approval inspections and commercialization readiness activities.
• Prior experience in an organization transitioning from clinical-stage development to commercial-stage operations.

Responsibilities

• Develop, lead, and execute 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 for pivotal development, registration-enabling activities, and lifecycle management.
• Assess evolving global regulatory expectations and translate regulatory intelligence into program strategies.
• Provide strategic leadership on manufacturing changes, comparability approaches, control strategies, process validation, analytical method evolution, and product lifecycle planning.
• Lead Regulatory CMC planning and execution for marketing authorizations and future geographical expansion.
• Establish regulatory strategies for phase-appropriate control systems, validation plans, potency methodologies, and commercial specifications.
• Lead development of integrated submission strategies supporting development and commercialization objectives.
• Lead Regulatory CMC interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global agencies.
• Lead preparation of CMC briefing packages, responses, meeting materials, and negotiation strategies.
• Provide executive-level guidance on regulatory risks, agency feedback, and evolving expectations for advanced therapies and genetic medicines.
• Represent Solid as a scientific and regulatory expert in agency meetings and industry forums.
• Provide strategic oversight of regulatory activities for manufacturing network expansion, technology transfer, process changes, and lifecycle management.
• Guide regulatory assessments of manufacturing changes, comparability data, process performance qualification activities, and commercial supply strategies.
• Partner with Technical Operations to ensure regulatory alignment across internal and external manufacturing organizations.
• Support global post-approval regulatory strategies that maximize operational flexibility while maintaining regulatory compliance.
• Contribute to the development of Regulatory CMC capabilities as Solid advances toward commercialization.
• Represent Solid in industry consortia, trade associations, and gene therapy working groups.

Benefits

• Competitive health and dental programs with flexible plan offerings, including FSA and HSA programs.
• 401(k) program with competitive company matched contributions.
• Eligibility to participate in Solid’s Employee Stock Purchase Plan.
• Mobile phone subsidy for eligible employees.
• Tuition reimbursement.
• Vision coverage.
• Life insurance.
• Voluntary pet insurance.
• Employee discount program on travel, entertainment, and services.
• Employee assistance programs.
• Daily subsidized lunch delivery for employees onsite at Hood Park.
• Free onsite full-service gym for employees onsite at Hood Park.
• Employee parking for employees onsite at Hood Park.
• 12 observed holidays and a winter shutdown.
• 15-day PTO policy with an 80-hour year-over-year rollover.
• 40-hour sick policy.
• 8-hour floating holiday.
• Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for regular employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Director