Associate Director, RA CMC

📋 Description

• The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with
• Prepares CMC regulatory strategies that enable first pass approvals.
• Develops and manages content strategy for regulatory submissions, including INDs/CTAs and
• Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations
• Serves as strategic liaison with regulatory agencies (e.g., FDA) regarding CMC matters.
• Trains, develops and mentors individuals; may include formal supervisory responsibilities.

🎯 Requirements

• Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering
• Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership.
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• 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. Strong oral and written communication

🎁 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.
• Equality and inclusion practices as part of AbbVie’s commitment to equal opportunity.