Associate Director, RA CMC

📋 Description

• Prepares CMC regulatory product strategies and manages submissions
• Analyzes information impacting regulatory decisions; seeks expert advice as needed
• Reviews and revises submissions to present data to agencies
• Develops strategies for agency meetings; manages content of submissions
• Manages product changes and change control per regulations and policies
• Represents CMC RA on cross-functional teams to drive first pass approvals

🎯 Requirements

• Bachelor's Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related
• 8 years pharmaceutical with at least 3 years of leadership
• 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in
• Experience developing and implementing global regulatory strategies; experience with Health
• Experience in a complex and matrix environment
• Strong oral and written communication skills

🎁 Benefits

• Competitive benefits package including paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) plan to eligible employees
• Eligible to participate in long-term incentive programs