Associate Director, RA CMC

📋 Description

• Lead CMC regulatory strategy for product approvals
• Prepare regulatory submissions (INDs/CTAs, amendments)
• Coordinate with RA, Operations, and R&D teams
• Engage with regulatory agencies (FDA) on CMC matters
• Manage change control and product lifecycle regulatory activities
• Mentor team members and drive RA CMC initiatives

🎯 Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related
• 8 years pharma experience with 3+ years leadership
• 10 years pharma with 5+ years in RA or related areas preferred
• Experience with global regulatory strategies and Health Authority interactions
• Strong written and oral communication skills
• Regulatory affairs in complex, matrix environments

🎁 Benefits

• Comprehensive benefits package
• Eligibility for long-term incentive programs
• Paid time off, medical/dental/vision coverage
• Equal opportunity employer