Associate Director, Regulatory Strategy

Solid Biosciences•Boston, MA

5d•$170,000 - $220,000•Hybrid

About The Position

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 an Associate Director, Regulatory Strategy, to advance and execute end-to-end regulatory strategies that enable efficient program progression across all stages of development. Reporting to the Director, Regulatory Strategy, the candidate will support Solid’s regulatory strategy and process, playing an active role in agency interactions, applications, and driving innovative regulatory pathways to support gene therapy development. A motivated and agile regulatory professional who is keen to be part of a collaborative team with a goal to develop global regulatory experience in gene therapy drug development will thrive in this role. This role will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA and is a hybrid position averaging 2-3 days per week in the office.

Requirements

PharmD or PhD preferred. Minimum of 6 years of experience in regulatory affairs in the biotech/pharma industry, including IND activity, global CTAs, DSURs, and agency briefing documents in US and ex-US.
Strong knowledge of US regulations and guidances pertaining to the conduct of investigational drug studies; ex-US experience highly desirable .
Self-starter mentality, with the ability to independently and effectively organize and prioritize tasks to achieve established deadlines.
Ability to work both independently and collaboratively 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.
Creative problem solving and strategizing abilities.

Nice To Haves

Strong preference for candidates with prior small biotech experience.
Experience in gene therapy and/or rare disease programs a plus, although not required.

Responsibilities

Serve as an active representative of Regulatory on interdisciplinary teams internally (Clinical Study Teams, Program Teams, etc.) and with external partners (CROs, consultants).
Drive the development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development.
Collaborate with cross-functional teams to generate and refine the product development strategy and identify potential regulatory risks.
Lead global clinical trial applications including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
Drive regulatory submissions, including necessary cross-functional teams and timelines, relevant to assigned projects or programs.
Actively contribute to the preparation and execution of 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.
Actively monitor regulatory policy and intelligence and disseminate information to inform program strategy.
Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence.
Actively monitor regulatory policy and intelligence and disseminate information to teams.

Benefits

Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Employee Assistance Programs
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)
12 Observed Holidays and a winter shut down
15-day PTO Policy and a 40-hour rollover YoY
40-hour Sick Policy
8 Hour Floating Holiday