Director, Regulatory Strategy

Director, Regulatory Strategy – Solid Biosciences 

Charlestown, MA HQ

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.

We are 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.

This role will report to the Executive Director, Regulatory Strategy and will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA and is a hybrid position. 

Key Position Responsibilities 

• 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.

Experience Requirements

• 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.

Key Position Attributes 

• 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.

Compensation 

The base compensation range for this role is: $190,000 - $240,000.
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance. 

Benefits and Solid Advantages 

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.