Associate Director, Regulatory Affairs

REGENXBIO; United States; Remote; USD 160,000 - 218,000; Full time

Benefits offered by this job

Annual bonus program

Education assistance

Retirement plan with company match

Stock options

Job summary

REGENXBIO Inc. is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategy for a therapeutic area from early development through marketing authorization, translating complex requirements into clear paths forward and shaping health authority interactions.

You will partner across functions to keep programs moving, drive submissions, and develop high-quality dossiers while collaborating with EU, Japan, and other markets. Occasional travel up to 15% is expected.

Qualifications

• Bachelor's degree; advanced degree preferred in biological sciences.
• 6–8 years of Regulatory Affairs experience including product approval/launch.
• Experience in biologics, orphan diseases, or CNS development preferred.
• Proven ability to prepare high-quality FDA/EMA submissions and HA meeting materials.
• Strong written and verbal communication; build trusted relationships.

Responsibilities

• Set and drive global regulatory strategy from early interactions through BLA/MAA.
• Lead submission activities and regulatory writing across submissions.
• Partner across development, commercialization, lifecycle management.
• Develop innovative regulatory strategies with cross-functional teams.
• Support commercial activities with regulatory labeling guidance.
• Lead and develop team members through hiring and coaching.
• Travel up to 15% as required.

Skills

Regulatory strategy

FDA submissions

Health Authority meetings

Cross-functional collaboration

Biologics experience

Education

Bachelor's degree

Advanced biology degree

Job description

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.
• Lead and develop one or more team members through hiring, training, clear expectations, coaching, and ongoing development.
• 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.