Vice President, Regulatory Affairs

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

Who We Are

Osanni is a development-stage therapeutics platform, headquartered in San Francisco, California. We are creative and agile innovators, relentlessly curious about finding new ways to target the biology behind diseases with the greatest unmet need and determined to do something about it.

Who We Are

Osanni is a development-stage therapeutics platform, headquartered in San Francisco, California. We are creative and agile innovators, relentlessly curious about finding new ways to target the biology behind diseases with the greatest unmet need and determined to do something about it. At the center of Osanni is its innovation engine, which is optimized for discovering new scientific insights, designing novel drug concepts, and efficiently advancing programs to a meaningful proof-of-concept. Once a program is sufficiently de-risked, it graduates into its ecosystem of affiliate companies (Avians), which are equipped with the dedicated focus, specialized talent and support necessary to scale. Osanni's architecture marries the scientific depth and operational power of a centralized platform with the speed, agility and accountability of independent companies. The result: an opportunity to create and deliver more transformative medicines. We hold patients and the physicians who care for them as our North Star. It guides our purpose, sharpens our decision-making, and defines our impact. Osanni is currently advancing programs in ophthalmology, cardiology and beyond. We are building a highly skilled team, passionate about having an impact on human health. Be part of creating an organization where people enjoy their work and their colleagues, are valued for their individuality, and can't imagine working anywhere else.

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%).

Below is the expected base pay range for this position plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.

Base Pay

$330,000 - $350,000 USD

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We will provide an intellectually stimulating, collegial and fast-paced environment.