Associate Director, Regulatory Strategy

Associate Director of Regulatory Strategy

Solid Biosciences is seeking an Associate Director of Regulatory Strategy based in Charlestown with a hybrid option. We are seeking a creative and agile regulatory professional who is keen to be a part of a collaborative team with a goal to develop global regulatory experience in gene therapy drug development. The candidate will play an active role in agency interactions, applications, and innovative regulatory pathways that support gene therapy development. In addition to contributing to the regulatory strategy and process internally, we are seeking a candidate with strong interest in participating in trade organizations to contribute to shaping the broader regulatory community.

Key Duties & Accountabilities:

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

Core Competencies Required:

• Excellent verbal and written communication skills.
• Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling, and assignment of tasks.
• Strong collaborator with multi-disciplinary teams.
• Creative problem solving and strategizing abilities.

Knowledge: Education, Experience, & Skills:

• Bachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred.
• Minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US.
• Experience in gene therapy programs a plus, although not required.
• Strong knowledge of US and EU regulations and Guidance’s pertaining to the conduct of investigational drug studies.
• Ability to effectively organize and prioritize tasks to achieve established deadlines.
• Ability to work both independently and within project teams, committees, etc. to achieve group goals.

Travel Commitment:

• Minimal travel required

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