Associate Director, RA-CMC Post-Approval Lead

BioSpace; North Chicago (IL); On-site; USD 120,000 - 190,000; Full time

Job summary

AbbVie is seeking an experienced Regulatory Affairs professional to lead post-approval CMC submissions and manage CMC dossiers across global programs. You will author sections, coordinate with cross-functional teams, and coach junior staff.

You will develop content plans, ensure CTD formatting, and drive timelines while maintaining file-ability and regulatory compliance. Strong communication and project leadership are essential.

Qualifications

• BA/BS degree in Chemical, Biological Sciences or related discipline.
• 8 years pharmaceutical experience.
• Preferred: 10 years pharma experience including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing; 2+ years supervising employees.
• Experience in preparing CMC sections of regulatory dossiers including electronic submissions.
• Strong working knowledge of manufacturing unit operations or CTD structure.
• Superior oral and written communication skills.

Responsibilities

• Independently manage, compile, and author CMC sections of marketed product variations.
• Develop initial content plans, bundling strategies, and project timelines.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses; drive reviews with minimal intervention by project lead.
• Lead business-critical programs coordinating activities and resources across global programs for multiple post-approval changes.
• Ensure CTD content and formatting requirements are met; develop and train on best practices for regulatory systems.
• Provide tactical support to integrate technical issues with regulatory requirements and emerging standards.
• Identify content gaps and risks for variation documents and communicate them.

Skills

Regulatory leadership

Project management

Stakeholder communication

Detail orientation

Coaching

Education

BA/BS in Chemical or Biological Sciences

Tools

Electronic document management systems

Job description

AbbVie is seeking an experienced Regulatory Affairs professional to lead post-approval CMC submissions and manage CMC dossiers across global programs. You will author sections, coordinate with cross-functional teams, and coach junior staff.

You will develop content plans, ensure CTD formatting, and drive timelines while maintaining file-ability and regulatory compliance. Strong communication and project leadership are essential.