Senior Regulatory Affairs CMC, Post-Approval

Regulatory Jobs; Waltham (MA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Senior Associate, RA CMC to manage and author CMC sections for marketed product variations and to coordinate with RA CMC Project Leads on content plans, timelines, and submission strategies.

The role involves cross-functional collaboration, ensuring CTD compliance, and delivering high-quality regulatory documents. Hybrid work schedule, with locations in Lake County IL, Waltham MA, or Irvine CA.

Qualifications

• Minimum BA/BS in Chemical, Biological Sciences or relevant discipline.
• 4 years pharmaceutical or industry-related 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 oversight.
• Update simple CMC documents independently.
• Collaborate with RA CMC Project Leads to create content plans and timelines.
• Coordinate with diverse functional groups to ensure CMC dossier readiness and acceptance.
• Lead team reviews of submission documents and ensure CTD content and formatting requirements are met.
• Provide guidance on use of submission document templates and regulatory business systems.

Skills

Communication skills

CTD knowledge

Regulatory affairs

Project management

Cross-functional collaboration

Detail-oriented

Education

BA/BS in Chemical or Biological Sciences

Tools

EDMS

Job description

AbbVie is seeking a Senior Associate, RA CMC to manage and author CMC sections for marketed product variations and to coordinate with RA CMC Project Leads on content plans, timelines, and submission strategies.

The role involves cross-functional collaboration, ensuring CTD compliance, and delivering high-quality regulatory documents. Hybrid work schedule, with locations in Lake County IL, Waltham MA, or Irvine CA.