Associate Director, Regulatory CMC

Associate Director, Regulatory CMC – Solid Biosciences Location: Charlestown, MA HQ – hybrid option. 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, Friedreich’s ataxia, catecholaminergic polymorphic ventricular tachycardia, TNNT2‑mediated dilated cardiomyopathy, BAG3‑mediated dilated cardiomyopathy, and other fatal, genetic cardiac diseases. The company’s mission is to improve the daily lives of patients living with devastating rare diseases. Chemistry, manufacturing and controls (CMC) is central to program development, and the Regulatory CMC team provides a leadership role that bridges CMC development and regulatory strategy. Key Responsibilities Actively represent Regulatory CMC on interdisciplinary teams (e.g., CMC Teams, Program Teams) and with business partners such as consultants and CDMOs. Collaborate with cross‑functional teams to generate and refine product development strategy. Lead CMC content for global clinical trial applications, including preparation of INDs/CTAs/GMOs, amendments, responses to agency questions, and maintenance activities; prepare for later‑stage submission activities. Interface with CMC and quality teams, including execution of change management and data‑integrity processes. Drive and contribute to regulatory CMC content and submissions, coordinating cross‑functional teams, timelines, and milestones across assigned projects or programs. Actively contribute to the preparation and execution of global agency meetings. Support development and implementation of global regulatory CMC strategies, identifying regulatory risks to facilitate program progress through all phases. Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings. Experience & Qualifications Bachelor’s degree in a scientific discipline; Master’s, PharmD, or PhD preferred. Minimum 4 years of regulatory affairs experience in the pharmaceutical/biotech sector, including IND activity, global CTAs, BLAs/MAAs, and agency briefing documents in the U.S. and abroad. Knowledge of recombinant manufacturing processes and controls, with preference for mammalian culture processes. Experience in gene therapy programs (rAAV) and rare disease programs a plus, although not required. Strong knowledge of U.S. and EU regulations and guidances pertaining to the CMC aspects of biological product development. Experience in submission management and change management required. Key Position Attributes Ability to effectively organize and prioritize tasks to meet deadlines. Ability to work independently and within project teams or committees, both face‑to‑face and remote. Excellent verbal and written communication skills; ability to author and edit CMC content. Excellent organizational and program‑management skills ensuring timely completion of objectives. Strong collaborator with multidisciplinary teams. Creative problem‑solving and strategizing abilities. Compensation Base pay range: $170,000.00/yr – $220,000.00/yr. Base salary determined through internal analysis based on skills, experience, location, and equity. Regular employees are eligible for short‑term and long‑term incentives, including cash bonus and equity opportunities. Benefits & Solid Advantages Competitive health and dental programs with flexible plan offerings, including FSA and HSA. 401(k) program with competitive company‑matched contributions. Eligibility to participate in Employee Stock Purchase Plan. Mobile phone subsidy. Tuition reimbursement. Vision coverage. Life insurance. Voluntary pet insurance. Employee discount program (travel, entertainment, services). Daily subsidized lunch delivery (onsite @ Hood Park). Free onsite full‑service gym (onsite @ Hood Park). Employee parking (onsite @ Hood Park). Seniority Level Mid‑Senior level Employment Type Full‑time #J-18808-Ljbffr