💼 About This Role

You'll lead CMC regulatory strategy and operations for a biotech focused on therapies targeting aging biology. You'll own global regulatory plans and submissions for cell therapy and small molecule programs, directly supporting high-stakes health authority interactions. This role offers the chance to build regulatory capabilities in a mission-driven, early-stage company.

🎯 What You'll Do

• Develop and execute global CMC regulatory strategy for each program
• Lead preparation of CMC dossiers for INDs/CTAs and marketing applications
• Act as regulatory liaison with health authorities for CMC communications
• Identify CMC risks and create innovative mitigation strategies

📋 Requirements

• 7+ years of hands-on experience in regulatory CMC
• Bachelor's degree in life sciences or equivalent (advanced degree preferred)
• Cell therapy CMC regulatory strategy experience
• Early phase development experience (IND/CTA through Phase 1/2)

✨ Nice to Have

• Experience with iPSC-derived cell therapies
• Experience across multiple product modalities (cell/gene therapy, small molecules, biologics)
• Late phase and global regulatory experience

🎁 Benefits & Perks

• 🏖️ Unlimited PTO
• 🏥 Comprehensive health insurance
• 📈 Equity grants
• 🧘 Wellness benefits
• 🍽️ Catered lunches

🚩 Heads Up

• Role mixes cell therapy and small molecule regulatory work, which are distinct domains
• Requires 7+ years but title implies lead level (potential mismatch)
• Onsite requirement in Redwood City for a role that could be remote