💼 About This Role

You'll lead global regulatory strategies for innovative oncology therapies at a clinical-stage company. Your work will shape regulatory submissions and Health Authority interactions for blockbuster potential programs like palazestrant. This role stands out for its impact on breast cancer treatments and cross-functional leadership.

🎯 What You'll Do

• Develop innovative global regulatory strategies for Olema's product portfolio
• Lead regulatory submissions including INDs, NDAs, and BLAs
• Represent Regulatory Affairs on cross-functional teams and lead Agency interactions
• Identify regulatory gaps and develop risk mitigation strategies

📋 Requirements

• 12+ years in Regulatory Affairs in pharma/biotech
• Minimum 3 years direct leadership experience
• Experience with NDA/BLA or marketing applications
• Oncology therapeutic area experience required

✨ Nice to Have

• Advanced degree (Masters, PharmD, or PhD)
• Experience with global Health Authorities (FDA, EMA, etc.)

🎁 Benefits & Perks

• 💰 Competitive compensation including base pay, equity, and bonus
• 🏥 Comprehensive benefits package
• 🏢 Flexible work environment
• 📈 Long-term career development

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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