Vice President, Regulatory Affairs
Vice President, Regulatory Affairs
Location: Bay Area, CA (Hybrid – 2 days/week in-office preferred)
Remote candidates based in the Pacific Time Zone will also be considered
About the Role
We are seeking a strategic and experienced regulatory leader to join our growing team as Vice President, Regulatory Affairs. This individual will lead regulatory strategy for our Ophthalmology therapeutic area, including late-stage programs advancing toward BLA and MAA filings, and early-stage programs with significant growth potential. While we are targeting a VP level, exceptional Executive Director-level candidates will also be considered.
This role is ideal for a hands-on leader who thrives in a small but expanding regulatory group, can wear multiple hats, and is energized by working across development and commercial stages.
Key Responsibilities
Lead regulatory strategy and execution for Ophthalmology programs, from late-stage through potential commercialization.
Oversee preparation and submission of BLA, MAA, and other regulatory filings; NDA experience also considered.
Partner cross-functionally with clinical, CMC, and commercial teams to align on regulatory pathways.
Provide strategic input into early development programs in Ophthalmology, with potential expansion into additional indications.
Represent Regulatory Affairs in high-level internal and external meetings, including with regulatory authorities.
Mentor and guide direct reports
Qualifications
PhD/PharmD with 15+ years or BS/MS with 20+ years of relevant regulatory experience in biotech/pharma.
Proven track record of successful BLA/MAA (and/or NDA) submissions.
Therapeutic experience in Ophthalmology strongly preferred; rare disease experience a plus.
Broad regulatory background (development through commercialization) with ability to act as a generalist when needed.
Demonstrated leadership skills and the ability to influence across functions.
Why Join Us?
Impact: Lead strategy for programs on the cusp of commercialization while shaping the future of an expanding therapeutic area.
Growth: Join a company transitioning from a development-stage to a fully commercial organization, with a strong pipeline and a committed leadership team.
Culture: Collaborative, fast-moving, and hands-on environment where your expertise will make a visible difference.
Interested in the VP of Regulatory role? Please apply directly and email me at Dakota.Lowe@TreblaTalent.com.