Director, Regulatory Strategy

Job Title

Director, Regulatory Strategy

Reports To (title)

Executive Director, Regulatory

Solid Summary

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.

Position Summary

Solid Biosciences is seeking a 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 contributes 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

• 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.
• 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 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.
• Experience in gene therapy programs is a plus, although not required.
• Strong knowledge of US and EU regulations and Guidance’s pertaining to the conduct of investigational drug studies.
  
  

Travel Commitment

Minimal Travel

Role Location

(HQ, Hybrid, Remote, NC, etc.)

Charlestown, MA (HQ)/ Hybrid