Solid Biosciences · 22 hours ago
Regulatory Strategy Manager
Charlestown-HQ, Charlestown, MA, US
Full-time
Hybrid
Entry, Mid Level
$125K/yr - $160K/yr
2+ years expSolid Biosciences is a precision genetic medicine company focused on advancing gene therapy candidates for rare diseases. The Regulatory Strategy Manager will develop global regulatory strategies, support clinical trials, and interact with regulatory agencies to facilitate drug development processes.
BiotechnologyGeneticsHealth CareMedical
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
Qualification
Required
Bachelor's degree in a scientific discipline
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
Preferred
Masters, PharmD, or PhD
Experience in gene therapy programs and/or rare disease
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
Company
Solid Biosciences
Solid Biosciences is a life science company that conducts research for the treatment of Duchenne muscular dystrophy.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$810.3MKey Investors
Ultragenyx PharmaceuticalPerceptive AdvisorsJP Morgan
2025-02-18Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $109M
2022-09-30Post Ipo Equity· $75M
Leadership Team
Alexander Cumbo
CEO and President
Kevin Tan
Chief Financial Officer
Recent News
Pharmaceutical Technology
2026-01-16
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