Associate Director, RA CMC

📋 Description

• The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with
• Responsibilities

• 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

Qualifications

• 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

• AbbVie offers a comprehensive package of benefits including paid time off, medical/dental/vision
• This job is eligible to participate in our long-term incentive programs.
• Equal Opportunity Employer; information on accommodations and equal opportunity policies available