Director, Regulatory Affairs

Regenxbio•Rockville, MD

9d•$0 - $1•Onsite

About The Position

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.

Requirements

Doctorate level or masters required (MD or PhD, MS in Science/Biotechnology/Regulatory or equivalent) with at least 10 years of relevant experience required.
Demonstrated ability to lead and motivate people
Ability to proactively predict issues and solve problems.
Flexible, resilient, resourceful, entrepreneurial, innovative, and conducts all activities in a highly ethical manner
Experience with global regulatory quality requirements
Proactive approaches to problem-solving with strong decision-making capability
Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and health authorities

Nice To Haves

Experience in gene therapy preferred.
Experience with preparation of high-quality FDA/EMA submission documentation and Health Authority meeting preparations preferred

Responsibilities

Develop 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.