Associate Director, RA CMC

📋 Description

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages
• Manages products and change control with an understanding of regulations and company policies and
• Represents CMC regulatory affairs on teams such as the product development, Global Regulatory

🎯 Requirements

• Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership
• Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory
• Experience developing and implementing successful global regulatory strategies. Experience working
• Experience working in a complex and matrix environment.

🎁 Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs