Job Details

Base pay range

$310,000.00/yr - $350,000.00/yr

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. Remote candidates based in the Pacific Time Zone will also be considered.

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 ...@TreblaTalent.com.

Seniority level

• Executive

Employment type

• Full-time

Job function

• Strategy/Planning and Other

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

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