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.
FAQs
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