---
title: 'Associate Director, Regulatory Affairs at REGENXBIO'
canonical: 'https://feeny.ai/job/associate-director-regulatory-affairs-regenxbio-rockville-1grfyr3vz4sy'
type: 'job'
last_seen: '2026-11-02'
---

# Associate Director, Regulatory Affairs at REGENXBIO

- **Company:** REGENXBIO
- **Location:** Rockville, MD
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-09-29
- **Last confirmed live:** 2026-11-02
- **Apply:** https://jobs.lever.co/regenxbio/5dd3d374-c2fa-4422-ab74-9ae7b83ec2a6

## 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.

## About REGENXBIO

## Company Overview
- **One-liner**: REGENXBIO is a clinical-stage biotechnology company developing one-time gene therapies for rare and retinal diseases using its proprietary AAV vector platform.
- **Entity Type**: Public (NASDAQ: RGNX)
- **Headquarters**: Rockville, Maryland, United States
- **Founded**: 2008 (founded as a company; operations began in 2009)
- **Founders**: Not publicly listed as individual founders; the company was spun out from the gene therapy research of the University of Pennsylvania and licensed its NAV Technology Platform from the university.

## Core Business
- **Primary industry**: Biotechnology – Gene Therapy (AAV-based)
- **Target customers**: B2B (pharma partners like AbbVie, Nippon Shinyaku) and B2G (regulatory agencies, clinical trial sites); ultimate customers are patients with rare and retinal diseases (Duchenne muscular dystrophy, MPS I, MPS II, wet AMD, diabetic retinopathy).
- **Mission or purpose statement**: “To improve lives through the curative potential of gene therapy.” [regenxbio.com](https://www.regenxbio.com/culture-careers/)

## Products & Services
- **NAV® Technology Platform**: Proprietary AAV vector gene delivery platform (including AAV8 and AAV9) used for internal programs and licensed to partners (e.g., Novartis for ZOLGENSMA®).
- **ABBV-RGX-314** (in collaboration with AbbVie): Investigational one-time gene therapy for wet age-related macular degeneration (wet AMD) and diabetic retinopathy (DR). In pivotal clinical trials.
- **RGX-202** (Duchenne muscular dystrophy): Phase I/II/III AFFINITY DUCHENNE® trial; pivotal phase expected to support BLA submission in 2026 using accelerated approval pathway. [ir.regenxbio.com](https://ir.regenxbio.com/static-files/92731f97-50e3-4285-b793-d2cdc99611aa)
- **RGX-121** (MPS II – Hunter syndrome): In partnership with Nippon Shinyaku; late-stage development.
- **RGX-111** (MPS I – Hurler syndrome): In partnership with Nippon Shinyaku; clinical development.
- **Manufacturing**: In-house cGMP production facility (REGENXBIO Manufacturing Innovation Center – RMIC) in Rockville, MD, operational since mid-2022.

## Market Standing
- **Valuation/Market Cap**: $447.8 million (as of recent data). [linkedin.com](https://linkedin.com/company/regenx)
- **Key Metric**: Annual Revenue $170.4 million (primarily from license and collaboration revenue). [linkedin.com](https://linkedin.com/company/regenx)
- **Notable Investors/Partners**:
    - AbbVie (collaboration for ABBV-RGX-314)
    - Nippon Shinyaku (partnerships for RGX-121 and RGX-111)
    - Novartis (licensee for ZOLGENSMA® using NAV vectors)
- **Growth Signals**:
    - Headcount: 296 employees (+1.3% YoY). [linkedin.com](https://linkedin.com/company/regenx)
    - BLA submission for RGX-202 targeted for 2026.
    - RMIC facility operational since 2022, enabling scalable clinical and commercial manufacturing.
    - Scholarly output: 160 works, 7,337 citations, field-weighted citation impact of 2.6 (highly influential). [linkedin.com](https://linkedin.com/company/regenx)

## Competitive Advantages
- **Proprietary NAV Technology Platform**: Exclusive rights to a large portfolio of AAV vectors (including AAV8 and AAV9), the foundation for multiple approved and investigational gene therapies. [ir.regenxbio.com](https://ir.regenxbio.com/static-files/92731f97-50e3-4285-b793-d2cdc99611aa)
- **End-to-end capabilities**: Integrated in-house R&D, preclinical development, clinical development, and cGMP manufacturing.
- **Proven platform**: Thousands of patients have been treated with AAV vectors from the NAV platform (including via Novartis’ ZOLGENSMA®).
- **Late-stage pipeline**: Multiple programs in pivotal or near-pivotal trials (RGX-202, ABBV-RGX-314) with clear regulatory pathways.

## Strategic Focus
- **Near-term**: Advance RGX-202 toward BLA submission in 2026; continue pivotal trials for ABBV-RGX-314 in wet AMD and diabetic retinopathy.
- **Long-term**: Expand pipeline in retinal, neuromuscular, and neurodegenerative diseases; leverage RMIC for commercial-scale manufacturing; deepen partnerships with AbbVie and Nippon Shinyaku.
- **Platform expansion**: Ongoing research to expand NAV vector capabilities and develop new AAV-based therapies.

## Why Work Here
- **Mission-driven culture**: “Patient-focused, driven by results, fosters collaboration.” Core values emphasize accountability, innovation, and serving patients with limited therapeutic options. [regenxbio.com](https://www.regenxbio.com/culture-careers/)
- **Impactful work**: Opportunity to work on one-time gene therapies that could fundamentally alter the course of devastating diseases.
- **Growth & stability**: Public company with late-stage pipeline, strong partnerships, and a clear path to commercialization.
- **Location & facilities**: Headquarters in Rockville, MD, with a state-of-the-art cGMP manufacturing facility (RMIC) on site.
- **Work policy**: Not explicitly stated as remote/hybrid; positions appear to be on-site (based on job listings in Rockville and field-based Medical Science Liaison roles).
- **Perks**: Comprehensive and competitive benefits for employees and families. [regenxbio.com](https://www.regenxbio.com/culture-careers/)
- **Engineering & science culture**: High scholarly output and citation impact; emphasis on cross-functional collaboration between research, manufacturing, and clinical teams.
- **Recruitment note**: REGENXBIO warns of fraudulent job offers; all applications go through their official Lever portal. [regenxbio.com](https://www.regenxbio.com/culture-careers/)

## Sources
1. [regenxbio.com – Culture & Careers](https://www.regenxbio.com/culture-careers/)
2. [linkedin.com – REGENXBIO company page](https://linkedin.com/company/regenx)
3. [ir.regenxbio.com – 10-K Filing (Business Overview)](https://ir.regenxbio.com/static-files/92731f97-50e3-4285-b793-d2cdc99611aa)
4. [ir.regenxbio.com – Investor Overview](https://ir.regenxbio.com/investor-overview)
5. [jobs.lever.co – REGENXBIO careers](https://jobs.lever.co/regenxbio)

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- [Head of Sales, Rare Disease](https://feeny.ai/job/head-of-sales-rare-disease-regenxbio-remote-qhp7fgpvfvzm)
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