Senior Global Regulatory Strategy Lead, Biologics

REGENXBIO Inc.; Rockville (MD); On-site; USD 160,000 - 218,000; Full time

Benefits offered by this job

Annual bonus

Education assistance

Paid caregiver leave

Stock options at all levels

Summer hours

Job summary

REGENXBIO Inc. in Rockville, MD, seeks an Associate Director, Regulatory Affairs to lead global regulatory strategy from early development through marketing authorization, translating complex requirements into clear paths forward and coordinating across functions.

You will drive submission activities, prepare FDA/EMA documentation, and guide labeling and promotional materials while shaping ex-US strategies with regional experts. Travel up to 15% may be required.

Qualifications

• Bachelor's degree; advanced degree preferred in biological sciences.
• 6–8 years of Regulatory Affairs experience with product approval/launch.
• Experience in biologics, orphan diseases, or CNS development preferred.
• Proven track record preparing high-quality submissions and Health Authority meetings.
• Strong written and verbal communication and stakeholder management.
• Ability to work across functions and independently.

Responsibilities

• 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/PIP, and pre-BLA/MAA meetings.
• Be a strategic regulatory partner across development, commercialization, and lifecycle management.
• Develop innovative regulatory strategies with cross-functional teams.
• Support commercial activities with regulatory guidance on labeling and promotion.
• Provide expert regulatory insight and market interpretation to global programs.
• Collaborate with regional experts to shape ex-US strategies and interact with authorities.
• Represent REGENXBIO with industry groups and partners.
• Travel up to 15% as required.

Skills

Regulatory strategy

Regulatory writing

Cross-functional collaboration

FDA/EMA submissions

Orphan/CNS experience

Education

Bachelor's degree in biological sciences

Advanced degree preferred

Job description

REGENXBIO Inc. in Rockville, MD, seeks an Associate Director, Regulatory Affairs to lead global regulatory strategy from early development through marketing authorization, translating complex requirements into clear paths forward and coordinating across functions.

You will drive submission activities, prepare FDA/EMA documentation, and guide labeling and promotional materials while shaping ex-US strategies with regional experts. Travel up to 15% may be required.