Associate Director, RA CMC

📋 Description

• Lead CMC regulatory product strategies and submissions (INDs/CTAs, amendments, variations)
• Collaborate with product development, RA, Operations, and R&D teams
• Represent CMC with regulatory agencies (e.g., FDA) as strategic liaison
• Prepare and manage regulatory submissions and responses
• Lead pre-meeting content and engagement with agencies
• Oversee change control and product/line approvals

🎯 Requirements

• Bachelor’s Degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field
• 8 years pharma experience with 3+ years in leadership
• 10 years pharma experience preferred; 5+ in regulatory affairs or 5+ in
• Experience with global regulatory strategies and Health Authority interactions
• Strong oral and written communication; ability to work in a matrix environment
• Higher education may compensate for years of experience

🎁 Benefits

• Competitive compensation and benefits package
• Long-term incentive programs eligibility
• Comprehensive health and retirement benefits