Director, European Regulatory Strategy

Solid Biosciences•Boston, MA

3d•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 accomplished Director of Regulatory Strategy to provide strategic, hands-on regulatory leadership for our clinical-stage gene therapy programs in neuromuscular and cardiac rare diseases. This position will require deep expertise in European regulatory policy, advanced understanding of gene therapy science, and proven experience shaping regulatory strategy through early and mid-stage clinical development. The Director will serve as a key regulatory thought partner to Clinical Development, CMC, science, commercial, and medical affairs teams with a strong focus on EMA, MHRA, and other European regulatory authorities. This role will report to the Vice President of Regulatory Strategy & Intelligence and will be based in Solid’s Corporate Headquarters in Boston, Massachusetts USA working in a hybrid capacity.

Requirements

PhD, MD, PharmD, or equivalent in life sciences required
10+ years of regulatory affairs experience required with at least 3 years in gene therapy
Demonstrated experience and expertise navigating European Regulatory agencies
Deep expertise in EMA and MHRA processes

Nice To Haves

Ability to work autonomously balanced with effective collaboration and coordination across regional and functional barriers
Nimble adaptability in working for a smaller scale organization (~125 employees) driving work independently while also evolving processes and systems to mature the regulatory function

Responsibilities

Develop and drive European and global regulatory strategies for clinical-stage neuromuscular and cardiac gene therapy programs
Serve as regulatory strategy lead for assigned programs collaborating with functional colleagues across CMC, Clinical, and science.
Act as an internal subject-matter expert on European ATMP regulatory policy
Lead regulatory interactions with EMA, MHRA, and EU national authorities in partnership with VP, Regulatory Strategy and SVP, Regulatory CMC
Prepare and manage scientific advice, protocol assistance, pediatric investigational plans, orphan drug applications, etc.
Contribute to global regulatory strategy alignment with US based programs
Work closely with the health economics team to drive and execute joint HTA and regulatory engagements
Provide strategic and hands-on input for CTAs and GMOs in the EU and UK
Support orphan designation, accelerated pathways, and regulatory filings
Partner cross-functionally to ensure regulatory readiness
Maintain expertise in gene therapy platforms (e.g., AAV)
Apply knowledge of neuromuscular and cardiac disease biology to regulatory strategy
Monitor evolving EU and UK gene therapy regulations

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
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)