Associate Director, Regulatory Affairs

Job overview

The Associate Director, Regulatory Affairs role is onsite in Rockville, MD, with an estimated compensation range of $160,000–$218,000 annually and travel up to 15% as required. REGENXBIO advances gene therapies for serious rare and retinal diseases.

What you'll do

• Lead global regulatory strategy for a therapeutic area from early development through marketing authorization.
• Direct submission activities and regulatory writing, support health authority interactions, advise on labeling and promotional materials, and collaborate across development, quality, manufacturing, supply chain, medical affairs, pharmacovigilance, and regulatory teams.

What we're looking for

Skills & competencies

rockville md

regenxbio

associate director

regulatory affairs

gene therapy

$160k–$218k/year

global regulatory strategy

fda submissions

ema submissions

health authorities

travel up to 15%

rare diseases

Work arrangement

• Weekend coverage required

Benefits & perks

• Annual bonus program, education assistance, paid caregiver leave, retirement plan with employer match, stock options, summer hours, and a comprehensive compensation and benefits package.

Why this role

The role spans global regulatory strategy, submission leadership, and health authority engagement across development and commercialization.

About the employer

Regenxbio is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.