Associate Director, RA-CMC PAC DM

📋 Description

• Independently manage, compile, and author CMC sections of marketed product variations.
• Develop content plans, bundling strategies, and project timelines.
• Collaborate with cross-functional teams to ensure file-ability of CMC sections.
• Oversee projects to ensure thoroughness, accuracy, and timeliness of dossiers.
• Lead programs coordinating activities and resources across global post-approval changes.
• Ensure CTD content and formatting requirements are met; train on best practices.

🎯 Requirements

• BA/BS in Chemical and/or Biological Sciences (or relevant).
• 8 years pharmaceutical experience; prefer 10 with 5+ in RA or 5+ in Discovery/Manufacturing.
• Experience preparing CMC sections for regulatory dossiers and electronic submissions.
• Strong knowledge of manufacturing unit operations or CTD structure.
• Excellent oral and written communication; can work with global teams.
• Experience with electronic document management systems; ability to multitask.

🎁 Benefits

• Comprehensive benefits package (vacation, holidays, health insurance, 401(k)).
• Eligibility for long-term incentive programs.
• AbbVie is an equal opportunity employer; committed to diversity and inclusion.