💼 About This Role

You'll lead global regulatory strategies for a biotech advancing breast cancer therapies, collaborating cross-functionally to shape submissions and Health Authority interactions. Your work will directly impact clinical development and lifecycle management of promising oncology assets.

🎯 What You'll Do

• Lead global regulatory strategy development for product portfolio
• Represent Regulatory Affairs as SME on cross-functional teams
• Prepare and manage regulatory submissions (INDs, CTx, NDA, BLA)
• Engage with health authorities and lead agency interactions

📋 Requirements

• 12+ years Regulatory Affairs experience in pharma/biotech
• 3+ years direct leadership experience
• Oncology therapeutic area experience required
• NDA/BLA submission leadership experience required

✨ Nice to Have

• Advanced degree (Masters, PharmD, PhD)
• Experience with companion diagnostics or devices
• Negotiation skills with FDA, EMA, Health Canada

🎁 Benefits & Perks

• 💰 Competitive compensation including equity and bonus
• 🏥 Comprehensive benefits package
• ✈️ Travel opportunities (up to 20% domestic/international)

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 45 min
3. 3Panel interview· 60 min
4. 4Executive interview· 45 min

🚩 Heads Up

• Requires 12+ years experience and NDA/BLA leadership for a Senior Director role (may be high bar)
• Mentions 'strong negotiation skills' as experience but not listed as requirement (potential mismatch)
• Vague 'flexible and proactive' attribute with no clear metrics