Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The opportunity
As the Director, Regulatory Affairs, you will develops and executes global regulatory strategies for early-stage and advanced therapy products, preparing key submissions and ensuring alignment with U.S. and international requirements. You’ll also monitor and interpret evolving regulatory and policy landscapes, engage with external stakeholders, and contribute to industry workgroups to inform development pathways. Additionally, you will build internal regulatory intelligence resources and partner cross-functionally to guide successful progression through pre-IND/CTA stages and the product lifecycle.
What you'll be doingDevelop regulatory strategies for new products and prepare and submit all necessary applications, reports, and correspondence to regulatory agencies. Familiarity with regulatory requirements in the United States and other regions is preferred.Monitor global and local regulatory environments affecting approval of advanced therapies and products of interest to REGENXBIO. Work closely with external agencies and other key stakeholders to gain understanding, advocacy, and alignment on desired endpoints. This includes serving as a visible external leader in professional societies such as ARM, BIO, and ASGCT as well as consortia such as BGTC.Anticipate the impact of the changing domestic and international regulatory environment, existing legislation and guidelines on the development of plans, registrational strategies, and post-marketing responsibilities. This includes research and regulatory intel (precedent, relevant preclinical and animal studies) for disease programs to inform preclinical development on design and acceptability of IND enabling requirements and clinical development activities. Actively contributing to key workgroups and drafting of guidance comments and policy documents. Build internal dashboard of regulatory science and policy resources including guidance documents, relevant regulatory decisions, and other content to inform changing regulatory landscape. Partner with the Regulatory Function to ensure regulatory strategy and execution for pipeline products in early-stage development are well aligned to ensure successful outcomes as programs advance to pre-IND/CTA stage and throughout product lifecycle for not only US licensing and marketing, but also other regions outside of the US . Working collaboratively across internal functions, author regulatory submission documents as needed to support REGENXBIO objectives.Travel up to 20% of the time is requiredIt is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:Doctorate level or masters required (MD or PhD, MS in Science/Biotechnology/Regulatory or equivalent) with at least 10 years of relevant experience required. Experience in gene therapy preferred. Demonstrated ability to lead and motivate peopleAbility to proactively predict issues and solve problems.Flexible, resilient, resourceful, entrepreneurial, innovative, and conducts all activities in a highly ethical mannerExperience with global regulatory quality requirementsProactive approaches to problem-solving with strong decision-making capabilityStrong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and health authoritiesExperience with preparation of high-quality FDA/EMA submission documentation and Health Authority meeting preparations preferred
