VP of Regulatory Affairs

Vice President, Regulatory Affairs - Rare Disease Focus
📍 San Francisco, Bay Area (On-site)
💰 Salary: $300,000 - $400,000 + Equity & Benefits

Are you ready to lead regulatory strategy at the forefront of rare disease innovation?

A pioneering biotech company with a late-stage clinical pipeline is seeking a visionary Vice President of Regulatory Affairs to drive global regulatory strategy across a portfolio of novel therapies targeting high-impact, complement-mediated diseases. This is a unique opportunity to shape the future of patient care while working alongside senior leadership in a high-visibility role.

🌟 Why This Role Matters

This isn't just another regulatory position. It's a chance to:

• Lead from the front on IND, CTA, NDA/BLA, and MAA filings across the US, EU, and global markets.
• Engage directly with FDA, EMA, PMDA, and other authorities to influence regulatory outcomes.
• Drive strategy for therapies with proof-of-concept data in multiple indications, including neurodegenerative and ophthalmic diseases.
• Mentor and build a high-performing regulatory team in a collaborative, fast-paced environment.
• Make a real impact on patients' lives by accelerating access to transformative treatments.

🧠 What You'll Bring

• 15+ years of Regulatory Affairs experience (PhD/PharmD) or 18+ years (BS/MS).
• Proven leadership in global regulatory submissions and agency interactions.
• Expertise in FDA/EMA regulations and CTD/eCTD formats.
• Strategic mindset with hands-on execution ability.
• Experience with rare diseases, biologics, and small molecules.

🎁 What You'll Get

• Executive-level visibility and influence in a mission-driven organization.
• Equity participation and a competitive base salary.
• Comprehensive benefits including medical, dental, vision, 401(k), and flexible spending plans.
• Work-life balance with flexible schedules and commuter support (BART, CalTrain, Ferry shuttle).
• A culture of inclusion that values diverse backgrounds and unconventional paths.

If you're ready to take your career to the next level and help bring life-changing therapies to patients faster, we want to hear from you.

📩 Apply now to explore this confidential opportunity.