💼 About This Role

You'll lead regulatory strategies for drug development programs from preclinical to approval. You'll mentor the regulatory team and ensure compliance with global regulations. This role offers telecommuting flexibility.

🎯 What You'll Do

• Develop and implement regulatory strategies for clinical programs
• Prepare and lead teams through regulatory meetings
• Lead authoring and review of regulatory documents
• Mentor and develop the Regulatory Affairs team
• Lead inspection readiness activities

📋 Requirements

• 10 years of experience in regulatory affairs
• Master's degree in Regulatory Science or related field
• Regulatory Affairs Certification (RAC)
• Experience with IND, CTA, NDA/MAA submissions

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Application Review· 1-2 weeks
2. 2Phone Screen· 30 min
3. 3Interview Loop· 2-3 hours