Associate Director, Regulatory CMC

Role Summary

Associate Director, Regulatory CMC – Charlestown, MA. Lead regulatory CMC activities for gene therapy programs, partnering across interdisciplinary teams and external partners. Drive global regulatory CMC strategies, contribute to agency interactions and submissions, and participate in industry trade groups to influence the broader regulatory community. This role supports later-stage development of programs such as SGT-003 and reports to the Head of Regulatory CMC with a hybrid work arrangement.

Responsibilities

• Actively represent Regulatory CMC on interdisciplinary teams and with business partners such as consultants and CDMOs.
• Collaborate with cross-functional teams to generate and refine the product development strategy.
• Lead CMC content for global clinical trial applications including INDs/CTAs/GMOs and 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, including necessary cross-functional teams and timelines for assigned projects or programs.
• Actively contribute to the preparation and execution of global agency meetings.
• Support development and implementation of global regulatory CMC strategies, including identifying regulatory risks to advance programs through all development phases.
• Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings.

Qualifications

• Required: Bachelor’s degree in a scientific discipline; minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech sector, including IND activity, global CTAs, BLAs/MAAs and agency briefing documents in US and outside the US.
• Preferred: Masters, PharmD, or PhD.
• Required: Knowledge of recombinant manufacturing processes and controls; preference for mammalian culture processes.
• Preferred: Experience in gene therapy programs (rAAV) and rare disease programs.
• Required: Strong knowledge of US and EU regulations and guidances pertaining to CMC aspects of biological product development.
• Required: Experience in submission management and change management.

Skills

• Ability to effectively organize and prioritize tasks to meet deadlines.
• Ability to work independently and within project teams to achieve goals, including in-person and remote collaboration.
• Excellent verbal and written communication skills; ability to author and edit CMC content.
• Excellent organizational and program management skills to ensure timely completion of objectives.
• Strong collaboration with multi-disciplinary teams.
• Creative problem solving and strategic thinking abilities.