Regulatory Strategy Manager

Solid Biosciences • Boston, MA

1d • $125,000 - $160,000 • 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 a creative and agile regulatory professional who is keen to be a part of a collaborative, fast-paced team and is seeking to develop global regulatory experience in gene therapy drug development. The candidate will play an active role in agency interactions, INDs, CTAs, GMOs, PIPs, and innovative regulatory pathways that support gene therapy development.

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

• Bachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred. Minimum of 2 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
• Strong knowledge of US and EU regulations and Guidances pertaining to the conduct of investigational drug studies
• Ability to effectively organize and prioritize tasks to achieve established deadlines
• 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

Nice To Haves

• Experience in gene therapy programs and/or rare disease a plus, although not required

Responsibilities

• Actively represents Regulatory on interdisciplinary teams (e.g., Clinical Study Teams)
• Support US, EU, and global clinical trials including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities.
• Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development
• Offer submission strategies for development products and identifies potential regulatory risks
• Collaborate with cross-functional teams to generate and refine the product development strategy
• Responsible for coordinating and driving 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
• Act as regulatory representative at meetings with business partners such as CROs, consultants, etc.
• Act as resource for team on evolving regulatory requirements, regulatory precedents, and intelligence
• Ability to work both independently and within project teams, committees, etc. to achieve group goals.
• Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees