Associate Director, Regulatory Affairs

Regulatory Jobs; Rockville (MD); On-site; USD 160,000 - 218,000; Full time

Job summary

REGENXBIO is seeking an Associate Director, Regulatory Affairs to lead global regulatory strategy from early development through marketing authorization. You will translate complex requirements into clear paths, shape health authority interactions, and collaborate across functions to keep programs moving.

The role requires 6–8 years in Regulatory Affairs, with experience in biologics or CNS areas preferred, and teamwork with multiple stakeholders across regions.

Qualifications

• Bachelor's degree in biological sciences or related field; advanced degree preferred.
• 6–8 years in Regulatory Affairs with product approval/launch experience.
• Experience in biologics, orphan diseases, or CNS development preferred.
• Proven ability to resolve complex global regulatory issues and FDA/EMA submissions.

Responsibilities

• Set and drive global regulatory strategy from early interactions to BLA/MAA submission.
• Lead submission activities and regulatory writing for IND, PIP, Scientific Advice, End-of-Phase I/II, and pre-BLA/MAA materials.
• Act as strategic regulatory partner across development, commercialization, and lifecycle management.
• Provide regulatory insight to global programs and shape ex-US strategies with regional experts.
• Collaborate across R&D, Quality, Manufacturing, Medical Affairs, and Regulatory Affairs.

Skills

Regulatory strategy

Cross-functional collaboration

FDA/EMA experience

Global regulatory

Education

Bachelor's degree

Advanced degree preferred

Job description

Since our founding in 2009, REGENXBIO has pioneered what’s possible in gene therapy. Today, we are advancing a pipeline of gene therapies designed to improve the lives of patients facing serious rare and retinal diseases and preparing to bring innovative new medicines to patients.

Our work is fueled by purpose and urgency because every day matters to patients and their families. At REGENXBIO, you’ll find meaningful opportunities to grow, collaborate, and contribute to the advancement of potentially transformative gene therapies. Together, our talented team is working to make a meaningful difference for patients and their families.

What we do matters.

The opportunity

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.

How you'll contribute

• Set and drive global regulatory strategy from early Health Authority interactions through BLA/MAA registration.
• Lead critical submission activities and regulatory writing, including pre-IND, orphan/paediatric investigation plan (PIP), Scientific Advice, End-of-Phase I/II, and pre-BLA/MAA meeting materials.
• Be a strategic regulatory partner across development, commercialization, and lifecycle management for a therapeutic area.
• Bring a forward-looking regulatory perspective to potential new products, working cross-functionally to develop innovative strategies.
• Support commercial activities with regulatory guidance on labeling and promotional materials.
• Bring expert regulatory insight and market interpretation to global development programs.
• Work across R&D, Quality, Manufacturing, Supply Chain, Medical Affairs, Pharmacovigilance, and Regulatory Affairs to deliver high-quality dossiers and materials aligned with business priorities.
• Partner with regional experts in the EU, Japan, and other markets to shape ex-US strategies and lead interactions with local regulatory agencies.
• Represent REGENXBIO with industry teams, trade associations, and professional organizations.
• Travel up to 15% as required.

What you'll bring

• 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.

What you can expect

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.