Associate Director, Regulatory CMC

Role Summary

Associate Director of Regulatory CMC – lead regulatory CMC activities for gene therapy programs, contribute to global regulatory strategy, and represent Regulatory CMC in interdisciplinary teams. Based in Charlestown, MA with a hybrid option. Focused on SGT-003 as it advances in later-stage development and on shaping broader regulatory community involvement.

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 submissions.
• 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 cross-functional teams and timelines relevant to assigned projects.
• Contribute to the preparation and execution of global agency meetings.
• Support development and implementation of global regulatory CMC strategies, identifying regulatory risks to progress programs through all development phases.
• Represent Solid Bio Regulatory in pharmaceutical trade groups and meetings.

Qualifications

• Bachelor‚Äôs degree in a scientific discipline; Masters, PharmD, or PhD preferred. Minimum of 4 years of regulatory affairs experience in pharma/biotech, including IND activity, global CTAs, BLAs/MAAs and agency briefing documents in US and ex-US.
• Knowledge of recombinant manufacturing processes and controls; preference for mammalian culture processes.
• Experience in gene therapy programs (rAAV) and rare disease programs a plus but not required.
• Strong knowledge of US and EU regulations and guidances pertaining to CMC aspects of biological product development.
• Experience in submission management and change management.

Skills

• Ability to organize and prioritize tasks to meet deadlines.
• Ability to work independently and in teams, including remote collaboration.
• Excellent verbal and written communication; ability to author and edit CMC content.
• Strong organizational and program management skills; prioritization, scheduling, and task assignment.
• Strong collaboration with multi-disciplinary teams.
• Creative problem solving and strategic thinking.

Education

• As per Qualifications: Bachelor's required; advanced degrees preferred (Masters, PharmD, or PhD).

Additional Requirements

• Hybrid work arrangement in Charlestown, MA.