Solid Biosciences is a precision genetic medicine company headquartered in Charlestown, Massachusetts, focusing on advancing innovative gene therapy candidates
Director, European Regulatory Strategy
Location
United Kingdom + 9 moreAll locations: United Kingdom | Germany | France | India | Brazil | Australia | Estonia | Japan | Portugal | Sweden
Posted
85 days ago
Salary
$209.8K - $249.8K / year
Seniority
Lead
No structured requirement data.
Job Description
Director, European Regulatory Strategy
Solid Biosciences
Role Description 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 a remote, EU-based role. 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. Qualifications - 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. Requirements - 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. 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).
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