Director, European Regulatory Strategy at Solid Biosciences – Charlestown, Massachusetts

Director, European Regulatory Strategy – Solid Biosciences

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.

Key Position Responsibilities

• Regulatory Strategy & Leadership
  • 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
• Regulatory Agency Engagement
  • 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
• Submissions & Development Support
  • 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
• Scientific & Therapeutic Expertise
  • 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

Experience 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

Key Position Attributes

• 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

Compensation

The base compensation range for this role is: $209,757 - $249,831

Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.

• 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)