Regulatory Affairs CMC Specialist – Dossier & Submissions Lead

Regulatory Jobs; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Senior Associate, RA CMC to manage and author CMC sections for marketed product variations. You will collaborate with RA CMC project leads to align content plans, bundling strategies, and timelines.

The role requires strong communication, regulatory knowledge, and experience with document management systems. Minimum 4 years in pharma or related industry with 1–2 years in quality systems or cross-functional project management.

Qualifications

• Bachelor-level degree in chemical, biological sciences or related discipline is required.
• 4 years of pharmaceutical or industry experience; 1–2 years in quality systems or cross-functional project management.
• Preferred: 5 years of 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 oversight.
• Coordinate content plans, bundling strategies, and project timelines with RA CMC leads.
• Collaborate with cross-functional groups to ensure CMC dossier readiness and acceptability.
• Lead team reviews of submission documents and ensure CTD content compliance.
• Provide guidance on submission document templates and lifecycle processes.
• Support annual reports and renewals as needed.

Skills

CTD structure

Communication skills

Regulatory knowledge

Document management

Project management

Detail oriented

Independent work

Team collaboration

US/intl regs

Education

BA/BS in Chemical or Biological Sciences

Job description

AbbVie is seeking a Senior Associate, RA CMC to manage and author CMC sections for marketed product variations. You will collaborate with RA CMC project leads to align content plans, bundling strategies, and timelines.

The role requires strong communication, regulatory knowledge, and experience with document management systems. Minimum 4 years in pharma or related industry with 1–2 years in quality systems or cross-functional project management.