Associate Director, Regulatory CMC

Associate Director, Regulatory CMC – 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.

Chemistry, manufacturing and controls is at the forefront of development of our programs and regulatory CMC provides a leadership role in program teams and bridges CMC development and regulatory strategy.

We are 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 CMC experience in gene therapy drug development. The candidate will play an active role in agency interactions, applications, and innovative CMC development solutions in the rare disease space.

The role will lead regulatory CMC on SGT-003 as it moves into later stage development at a vital time in the program. The role offers wide exposure across the internal Solid teams as well as the opportunity to contribute to strategic reviews with senior management. 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 Head of Regulatory CMC and will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA and is a hybrid position.

• Actively represent Regulatory CMC on interdisciplinary teams (e.g. CMC Teams, Program Teams) and with business partners such as consultants, CDMOs etc.
• Collaborate with cross-functional teams to generate and refine the product development strategy.
• Lead CMC content for global clinical trial applications including the preparation of INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities. Prepare for later stage submission activities.
• 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 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 CMC strategies, including identifying regulatory risks, to facilitate the progress of programs through all phases of development.
• Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings.

• 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, BLAs/MAAs and Agency briefing documents in US and ex-US.
• Knowledge of recombinant manufacturing processes and controls required, with preference for mammalian culture processes.
• Experience in gene therapy programs (rAAV) and rare disease programs a plus, although not…