Senior RA-CMC Associate: Regulatory Submissions & Projects

Regulatory Jobs; Irvine (CA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

AbbVie seeks a Senior Associate, RA CMC to lead post-approval variation activities, author and compile chemistry, manufacturing, and control sections, and ensure timely submission readiness. The role requires collaboration with RA CMC Project Leads and multiple global groups to maintain CTD content and format standards.

You will manage multiple CMC dossiers, drive project plans, and communicate risks and content gaps while supporting annual reports and renewals.

Qualifications

• BA/BS in Chemical and/or Biological Sciences required.
• 4 years pharmaceutical or industry experience; 1–2 years in quality systems or cross-functional project management.
• Preferred 5 years pharmaceutical experience including 1–2 years in regulatory affairs or 1–2 years in Discovery, R&D, or Manufacturing.

Responsibilities

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight. Update simple CMC documents independently.
• Partner with RA CMC Project Leads to create content plans, bundling strategies, and project timelines.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently run team review and management reviews of submission documents.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Provide input into and utilize current best practices for use of regulatory business systems within the group.
• Timely communication of systems issues to management.
• Communicate content gaps and risks for variation documents identified by RA CMC Project Leads.
• Provide guidance on use of submission document templates.

Skills

CTD structure

Communication skills

Regulatory knowledge

Cross-functional collaboration

Electronic document management

Project management

Attention to detail

Independence under pressure

US/international regulatory exposure

Education

BA/BS in Chemical and/or Biological Sciences

Job description

AbbVie seeks a Senior Associate, RA CMC to lead post-approval variation activities, author and compile chemistry, manufacturing, and control sections, and ensure timely submission readiness. The role requires collaboration with RA CMC Project Leads and multiple global groups to maintain CTD content and format standards.

You will manage multiple CMC dossiers, drive project plans, and communicate risks and content gaps while supporting annual reports and renewals.