New · posted Oct 15
Regenxbio · Biotechnology
Associate Director, Regulatory Affairs
- Rockville, MD
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
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.
What you need
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'll do
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.
Pay
$160,000 – $218,000 a year
Employer providedAt 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.
Where you'll work
Rockville, MDHybridOpen in Maps (opens in a new tab)
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The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Maryland7 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $160,000 | — | $218,000 |
| Maryland (middle half) | $210,750 | $232,500 | $249,250 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Regenxbio's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Regenxbio's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Regulatory submissions7
- Documentation and SOPs3
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotion
From Regulatory News
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Associate Director, Regulatory Affairs at Regenxbio
Open until filled. $160K–$218K a year, employer provided.