Director, Regulatory Strategy

Role Summary

Director of Regulatory Strategy based in Charlestown, MA with a hybrid option. Responsible for developing and executing global regulatory strategies in gene therapy drug development, leading agency interactions, submissions, and contributing to shaping the broader regulatory community.

Responsibilities

• Actively represent Regulatory on interdisciplinary teams and with business partners such as CROs and consultants.
• Collaborate with cross-functional teams to generate and refine the product development strategy.
• Lead global clinical trial applications including initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
• Coordinate and drive regulatory submissions with cross-functional teams and timelines.
• Contribute to the preparation and execution of global agency meetings.
• Support development and implementation of global regulatory strategies, identifying regulatory risks to progress programs through all development phases.
• Lead applications for regulatory designations (e.g., Orphan Drug, Rare Pediatric Disease, Priority Medicines).
• Monitor regulatory policy and intelligence and disseminate information to inform program strategy.
• Represent Solid Regulatory through participation in pharmaceutical trade groups and meetings.

Qualifications

• Required: Bachelor’s degree in a scientific discipline; advanced degree (Masters, PharmD, or PhD) preferred.
• Required: Minimum of 8+ years of experience in regulatory affairs in pharmaceutical/biotech, including IND activity, global CTAs, DSURs, and agency briefing documents in US and ex-US.
• Preferred: Experience in gene therapy programs.
• Required: Strong knowledge of US and EU regulations and guidance pertaining to the conduct of investigational drug studies.

Skills

• Ability to organize and prioritize tasks to meet deadlines.
• Ability to work independently and within project teams.
• Excellent verbal and written communication skills.
• Strong organizational and program management skills to ensure timely objectives completion.
• Strong collaboration with multi-disciplinary teams.
• Creative problem solving and strategic thinking abilities.

Education

• Bachelor’s degree in a scientific discipline; advanced degree preferred.

Additional Requirements

• Hybrid work arrangement in Charlestown, MA.