Vice President, Regulatory Affairs

About the Role:

The Vice President, Regulatory Affairs is responsible for defining and executing the global regulatory strategy for Osanni’s programs, from IND through late-stage development and marketing applications. Reporting to the Chief Medical Officer, Ophthalmology this leader will serve as the primary voice with FDA, EMA, and other health authorities, own the planning and quality of all regulatory submissions, and build a regulatory function that scales with the company as programs advance through clinical development.

The ideal candidate is a strategic, hands-on regulatory leader who pairs deep scientific and regulatory judgment with the operational discipline to deliver high-quality submissions on aggressive timelines. They bring the integrity and sound judgment to care about getting it right for patients, the agility to adjust as priorities and agency feedback evolve, and a collaborative style that makes regulatory a trusted partner across Osanni.

What You Will Do:

• Lead the development and execution of global regulatory strategy for Osanni’s programs, beginning with MiraVi's ophthalmology pipeline, aligning regulatory pathways with clinical, CMC, and corporate objectives.
• Serve as the primary regulatory liaison with FDA, EMA, and other health authorities; plan, prepare for, and lead agency interactions including pre-IND, End-of-Phase 2, Scientific Advice, and pre-NDA/BLA meetings.
• Own the planning, authoring, review, and timely submission of regulatory filings, including INDs, CTAs, amendments, annual reports, briefing documents, and, as programs advance, NDA/BLA and MAA submissions.
• Partner with the Chief Medical Officer and Clinical Development to shape clinical development plans, protocol design, and endpoint strategy that support efficient regulatory approval.
• Collaborate with Clinical Operations on protocol submissions, safety reporting obligations, and inspection readiness across global trial sites.
• Work closely with CMC and Quality to define the regulatory strategy for drug substance and drug product
• Partner with Nonclinical, Biostatistics, and Drug Safety/Pharmacovigilance teams to ensure nonclinical packages, statistical analysis plans, and safety data meet regulatory expectations.
• Identify and evaluate expedited pathways and designations (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, PRIME) and lead the related applications where appropriate.
• Monitor the evolving regulatory landscape, including ophthalmology specific guidance and precedent, and translate intelligence into risk assessments and actionable recommendations for leadership.
• Build, lead, and develop the regulatory affairs function, including hiring and mentoring team members and selecting and managing regulatory consultants, CROs, and publishing vendors.
• Manage multiple priorities in a fast-paced, evolving environment, ensuring deliverables are completed accurately and on time, while performing other related duties as required.

What You Bring:

• Bachelor's degree in a life science or related discipline required; advanced degree (PhD, PharmD, MS, MPH, RN or MD) strongly preferred. RAC certification is a plus.
• 15+ years of regulatory affairs experience in the biopharmaceutical industry, including at least 5 years in a regulatory leadership role managing teams and external partners.
• Demonstrated success leading IND and CTA submissions and direct, face-to-face interactions with FDA and EMA; experience leading or making significant contributions to an NDA, BLA, or MAA approval strongly preferred.
• Ophthalmology drug development experience strongly preferred, including familiarity with ophthalmic endpoints, formulations, and routes of administration (e.g., topical, intravitreal).
• Solid working knowledge of FDA regulations, ICH guidelines, EU regulatory requirements, and eCTD structure and publishing.
• Strong understanding of CMC, nonclinical, and clinical regulatory requirements across the development lifecycle, with experience in small molecule, peptide, or biologic products.
• Experience in a venture-backed, development-stage biotech or similarly fast-paced environment, with a willingness to be both strategic and hands-on.
• Exceptional written and verbal communication skills, with the ability to distill complex regulatory issues into clear recommendations for executives, Board members, and investors.
• Collaborative, influential leadership style with sound judgment, high integrity, and the ability to build trust across functions and with health authorities.
• Ability to travel domestically and internationally as needed for agency meetings, team gatherings, and partner engagements (approximately 15 to 20%).