Remote Global Regulatory Lead, Ophthalmic Biotech

Outlook Therapeutics Inc.; Tulsa (OK); On-site; USD 195,000 - 255,000; Full time

Benefits offered by this job

Competitive base salary + equity

Comprehensive health coverage

401(k) with company match

Generous paid time off

Direct access to leadership

Job summary

Outlook Therapeutics Inc. is seeking an experienced Regulatory Affairs leader to own global filings and engage health authorities across US, EU, UK, and expansion markets.

You will manage BLA/MAA lifecycle submissions, CTAs, INDs, and briefing documents, working with senior leadership to drive timely regulatory decisions. The role requires 8+ years in biotech regulatory affairs, strong CMC literacy, and experience with biologics and combination products.

Qualifications

• Bachelor’s degree in life science; advanced degree preferred.
• 8+ years in regulatory affairs with progressive ownership of filings.
• Experience preparing and submitting BLAs, MAAs, INDs, CTAs.
• Global filings experience across markets for biologics and devices.
• Strong interaction with health authorities (FDA, EU/UK).

Responsibilities

• Own end-to-end preparation, compilation, and submission of regulatory filings globally.
• Lead health authority engagements and meetings with strategy and briefing materials.
• Drive advertising/promotional material reviews in line with regulations.
• Coordinate with CROs, consultants, and in-country reps; manage vendor networks.
• Develop regulatory strategy and ensure submission-ready documentation with cross-functional partners.

Skills

FDA/EMA liaison

Global regulatory filings

BLA/MAA/IND/CTA submissions

Biologics regulatory strategy

Combination products expertise

Education

Bachelor’s degree in life science

Advanced degree preferred

Job description

Outlook Therapeutics Inc. is seeking an experienced Regulatory Affairs leader to own global filings and engage health authorities across US, EU, UK, and expansion markets.

You will manage BLA/MAA lifecycle submissions, CTAs, INDs, and briefing documents, working with senior leadership to drive timely regulatory decisions. The role requires 8+ years in biotech regulatory affairs, strong CMC literacy, and experience with biologics and combination products.