💼 About This Role

You'll define global regulatory strategies for novel ophthalmology products, leading health authority interactions and submission planning. Your leadership will drive approval pathways and cross-functional alignment across clinical, CMC, and commercial teams.

🎯 What You'll Do

• Define and execute global regulatory strategies for ophthalmology programs
• Lead health authority interactions (pre-IND, end-of-phase, pre-NDA/BLA)
• Oversee preparation and submission of global regulatory filings
• Mentor and develop regulatory team members

📋 Requirements

• 10–15+ years in Regulatory Affairs or regulated life sciences
• Global regulatory strategy experience in ophthalmology or drug development
• Bachelor's degree required; advanced degree preferred
• Proven ability to lead health authority interactions

✨ Nice to Have

• RAPS certification preferred
• Experience with combination products
• Advanced degree (Master's, PhD, PharmD)

🎁 Benefits & Perks

• 💰 Competitive base salary $165k-$220k
• 🏥 Comprehensive healthcare from day one
• 🏖️ Paid time off 3 weeks vacation, holidays, sick leave
• 📈 401(k) matching and employee stock purchase plan
• 📚 Tuition reimbursement for select programs

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Panel Interview· 1 hour