Global Regulatory Strategy Executive

Osanni Bio; United States; On-site; USD 330,000 - 350,000; Full time

Job summary

Osanni Bio is seeking an experienced Vice President, Regulatory Affairs to define and execute the global regulatory strategy for its ophthalmology-focused programs. Reporting to the Chief Medical Officer, this leader will interact with FDA, EMA, and other health authorities, owning submissions and building a scalable regulatory function.

The ideal candidate combines strategic regulatory judgment with hands-on execution, delivering high-quality filings on aggressive timelines while mentoring a

Qualifications

• Bachelor’s degree in life science; advanced degree preferred.
• 15+ years in regulatory affairs in biopharma; leadership experience.
• Experience with IND/CTA submissions and agency meetings.
• Ophthalmology drug development experience preferred.
• Strong knowledge of FDA/ICH/EU regulations and eCTD.
• Experience in a venture-backed, fast-paced environment.

Responsibilities

• Lead global regulatory strategy for Osanni’s programs across ophthalmology.
• Serve as primary liaison with FDA, EMA and other authorities.
• Own planning, authoring, review, and timely submission of INDs, CTAs, amendments, NDA/BLA and MAA filings.
• Partner with Clinical Development to shape clinical development plans and endpoints.
• Collaborate with Clinical Operations on protocol submissions, safety reporting and inspections.
• Define regulatory strategy for drug substance and drug product with CMC/QA.
• Identify and pursue expedited pathways and lead related applications.
• Build and mentor the regulatory affairs team and manage consultants/CROs.
• Travel domestically and internationally for agency meetings and partner engagements.

Skills

Regulatory leadership

FDA/EMA liaison

IND/CTA submissions

Ophthalmology experience

CMC knowledge

Regulatory strategy

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in life science

Advanced degree (PhD/PharmD/MS/MPH/RN/MD)

RAC certification (a plus)

Tools

eCTD publishing knowledge

Job description

Osanni Bio is seeking an experienced Vice President, Regulatory Affairs to define and execute the global regulatory strategy for its ophthalmology-focused programs. Reporting to the Chief Medical Officer, this leader will interact with FDA, EMA, and other health authorities, owning submissions and building a scalable regulatory function.

The ideal candidate combines strategic regulatory judgment with hands-on execution, delivering high-quality filings on aggressive timelines while mentoring a