Associate Director, Regulatory Affairs

As Associate Director, Regulatory Affairs, you'll lead global regulatory strategy for a therapeutic area from early development through marketing authorization - translating complex requirements into clear paths forward, shaping health authority interactions, and partnering across functions to keep programs moving.

We are looking for someone who thrives in a collaborative, patient-focused environment and brings:

•  A bachelor's degree; an advanced degree in biological sciences is preferred.

•  6-8 years of Regulatory Affairs experience, including product approval/launch, plus deep knowledge of one or more therapeutic areas.

•  Experience in biologics, orphan diseases, or CNS development is preferred.

•  A track record of resolving complex global regulatory issues.

•  Hands-on experience preparing high-quality FDA/EMA submission documentation and Health Authority meeting materials.

•  Strong written and verbal communication skills and the ability to build trusted relationships with internal stakeholders, external partners, and health authorities.

•  A resourceful, collaborative style - and the ability to be equally effective working independently.

•  Proactive, creative problem-solving and strong decision-making skills.

At REGENXBIO, we're committed to fostering an environment where people can do meaningful work, grow professionally, and make an impact. Our core values – trust, accountability, perseverance, and innovation – drive everything we do.

We offer a comprehensive and competitive benefit & compensation package which includes market-competitive salaries, an annual bonus program, education assistance, paid caregiver leave, retirement plan with employer match, stock options at all levels, summer hours and more! The estimated compensation range for this role is $160,000 to $218,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.