Associate Director, Regulatory Affairs

Lever, Inc.; Rockville (MD); On-site; USD 160,000 - 218,000; Full time

Benefits offered by this job

Annual bonus

Education assistance

Retirement plan with employer match

Stock options

Summer hours

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 partner across functions to keep programs moving.

You will drive critical submissions, provide regulatory writing expertise, and support cross-functional teams to ensure alignment with business priorities.

Qualifications

• Bachelor's degree required; advanced degree preferred in biological sciences.
• 6–8 years of Regulatory Affairs experience including product approval/launch.
• Experience with biologics, orphan diseases, or CNS development is preferred.
• Hands-on experience preparing FDA/EMA submission materials and Health Authority meeting materials.

Responsibilities

• Set and drive global regulatory strategy from early Health Authority interactions through BLA/MAA registration.
• Lead submission activities and regulatory writing including pre-IND, PIP, Scientific Advice, End-of-Phase I/II, and pre-BLA/MAA materials.
• Collaborate across functions to deliver high-quality dossiers aligned with business priorities.
• Support regional strategies with EU, Japan, and other markets; shape ex-US strategies.

Skills

Regulatory strategy

Regulatory submissions

FDA/EMA submissions

Cross-functional collaboration

Regulatory writing

Health Authority interactions

Education

Bachelor's degree

Advanced degree in biological sciences

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

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.

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.