Director, Regulatory CMC

Job overview

The Director, Regulatory CMC works onsite in Charlestown, MA. The base salary range is $230,000–$260,000 per year. Solid Biosciences develops genetic medicine candidates for rare diseases, with a mission to improve the daily lives of patients. The director leads global regulatory CMC strategy for the company’s AAV gene therapy portfolio. The role partners with technical operations, quality, program leadership, and executives to advance development, registration, manufacturing expansion, and commercialization readiness.

What you'll do

• Develop and execute global Regulatory CMC strategies
• lead submission planning and registration readiness
• guide health authority interactions
• advise on manufacturing changes, comparability, validation, and lifecycle management
• partner with technical operations and quality
• represent the company in industry groups.

What we're looking for

Skills & competencies

director regulatory cmc

regulatory affairs

cmc strategy

biologics

aav gene therapy

health authority engagement

charlestown ma

solid biosciences

$230k–$260k

commercialization readiness

rare disease medicines

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, dental, and vision coverage
• FSA and HSA
• 401(k) match
• employee stock purchase plan
• tuition reimbursement
• life insurance
• pet insurance
• employee assistance
• PTO, sick time, holidays, and winter shutdown.

Why this role

Requires a scientific degree and 12+ years of Regulatory Affairs experience with significant CMC responsibility for biological products; AAV gene therapy experience is strongly preferred.

About the employer

Solid Biosciences is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.