Director, Regulatory CMC
About The Position
Solid Biosciences is 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.
Requirements
- BS, MS, PhD, PharmD or equivalent scientific degree.
- 12+ years of Regulatory Affairs experience with significant Regulatory CMC responsibility in biological products.
- Demonstrated success leading global Regulatory CMC strategy for biologics.
- Leadership of 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), 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 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.
- 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.
- 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.
- 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 strategies.
- Partner with Technical Operations to ensure regulatory alignment across internal and external manufacturing organizations.
- Support establishment of global post-approval regulatory strategies to maximize operational flexibility while maintaining regulatory compliance.
- Contribute to the evolution of Regulatory CMC capabilities as Solid advances toward commercialization.
- Represent Solid within 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 participation 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 (onsite @ Hood Park)
- Free Onsite Full-Service Gym (onsite @ Hood Park)
- Employee Parking (onsite @ Hood Park)
- 12 Observed Holidays and a winter shut down
- 15-day PTO Policy and an 80-hour rollover YoY
- 40-hour Sick Policy
- 8 Hour Floating Holiday
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
