Director, Regulatory CMC

Solid Biosciences Inc.; Boston, Charlestown (MA, NH); On-site; USD 230,000 - 260,000; Full time

Benefits offered by this job

Health & dental benefits

401(k) with match

Employee stock purchase plan

Onsite gym and facilities

Daily lunch delivery (onsite)

Job summary

Solid Biosciences seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for its AAV gene therapy portfolio. You will partner with Technical Operations, Quality, and executives to advance late-stage programs toward approval and commercialization.

The role requires deep regulatory CMC expertise for biologics and hands-on leadership of cross-functional teams in a fast-paced biotech setting, including interactions with FDA/EMA.

Qualifications

• 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.

Responsibilities

• Develop, lead and execute global Regulatory CMC strategies across Solid's portfolio.
• Serve as Regulatory CMC representative on cross-functional governance teams.
• Drive regulatory plans for pivotal development, registration-enabling activities, and lifecycle management.
• Assess regulatory expectations and translate intelligence into program strategies.
• Provide leadership on manufacturing changes, comparability, control strategies, and product lifecycle planning.
• Lead regulatory planning for marketing authorizations and geographical expansion.
• Prepare CMC submissions and interact with health authorities.

Skills

Regulatory strategy

Global submissions

Cross-functional leadership

FDA/EMA interactions

Biologics experience

GMP/CMC knowledge

Quality systems

Education

BS/MS/PhD/PharmD or equivalent

Tools

Regulatory affairs leadership tools

Job description

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Director, Regulatory CMC

.25 Charlestown-HQ, Charlestown, MA, US

Salary Range: $230,000.00 To $260,000.00 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 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.

Organizational & Industry Leadership

• 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.

Experience Requirements

Required

• 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.

Strongly Preferred

• 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.

Compensation

The base compensation range for this role is: $230,000.00 - $260,000.00

Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.

• 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