Associate Director, RA CMC

📋 Description

• Prepare CMC regulatory product strategies
• Manage regulatory submissions and amendments
• Analyze data for regulatory decisions
• Lead agency meeting prep and content
• Manage change control with regulations and policies
• Collaborate with cross-functional teams for first pass approvals

🎯 Requirements

• Bachelor’s in Pharmacy, Chemistry, Biology, or Pharmacology, Engineering
• 8 years pharma exp with 3+ years leadership
• 10 years pharma exp incl 5+ in RA or 5+ in Discovery/R&D/Manufacturing
• Global regulatory strategy experience with Health Authorities
• Strong oral and written comms

🎁 Benefits

• Comprehensive benefits package includes PTO, medical/dental/vision
• 401(k) to eligible employees