Senior RA-CMC Lead for Post-Approval Changes

AbbVie; North Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie in North Chicago, IL is seeking an experienced Regulatory Affairs - CMC professional to independently manage post-approval variation dossiers and author CMC sections. This role will ensure timely preparation of submission documents and coordinate with cross-functional partners globally.

You will lead, coach, and develop junior staff, drive programs across multiple post-approval changes, and ensure CTD content and formatting standards are met across projects.

Qualifications

• BA/BS degree in Chemical or Biological Sciences or related field.
• 8 years pharmaceutical experience; 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.
• Experience preparing CMC sections of regulatory dossiers and electronic submissions.

Responsibilities

• Independently manage, compile, and author CMC sections of marketed product variations.
• Develop initial content plans, bundling strategies, and project timelines with RA CMC leads.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage projects to ensure timeliness, accuracy, and thoroughness of CMC dossiers and responses.
• Lead programs through coordination of activities and resource management across global programs.
• Ensure CTD content and formatting meet expectations; train on best practices for regulatory systems.
• Provide tactical support to integrate technical issues with regulatory requirements.
• Identify content gaps and risks for variation documents; guide submission templates.
• Support annual reports and renewals as needed.

Skills

Regulatory affairs

CMC documentation

Project management

Mentoring/leadership

Education

BA/BS in Chemical or Biological Sciences

Tools

EDMS

Regulatory submissions software

Job description

AbbVie in North Chicago, IL is seeking an experienced Regulatory Affairs - CMC professional to independently manage post-approval variation dossiers and author CMC sections. This role will ensure timely preparation of submission documents and coordinate with cross-functional partners globally.

You will lead, coach, and develop junior staff, drive programs across multiple post-approval changes, and ensure CTD content and formatting standards are met across projects.