Global Regulatory Strategy Lead (Associate Director)

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

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.