Director, Regulatory CMC – Gene Therapy

Solid Biosciences Inc.; Boston, Charlestown (MA, NH); Sur place; USD 230 000 - 260 000; Plein temps

Avantages offerts par ce poste

Health & dental benefits

401(k) with match

Employee stock purchase plan

Onsite gym and facilities

Daily lunch delivery (onsite)

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

Global submissions

Cross-functional leadership

FDA/EMA interactions

Biologics experience

GMP/CMC knowledge

Quality systems

Formation

BS/MS/PhD/PharmD or equivalent

Outils

Regulatory affairs leadership tools

Description du poste

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.