Strategic Regulatory Affairs Lead — US & Canada

Regulatory Jobs; North Chicago (IL); On-site; USD 190,000 - 230,000; Full time

Job summary

AbbVie in North Chicago, IL seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead to develop and implement regulatory strategy for US and Canada, ensuring alignment with GRPT and timely filings.

You will coordinate data for filings, respond to inquiries, manage registrations, and liaison with FDA, working cross-functionally with Clinical Development, Legal and Commercial to support commercialization.

Qualifications

• Advanced degree or regulatory certification with minimum 5 years regulatory/R&D experience.
• Experience working in a complex, matrix environment with government agencies.
• Strong negotiation and communication skills; able to influence cross-functional teams.

Responsibilities

• Develop and implement US/Canada regulatory strategy for assigned products.
• Serve as HA liaison and interface with FDA for meetings and submissions.
• Advise internal customers on Regulatory/FDA issues and cross-functional impact.
• Prepare and review regulatory submissions and ensure timely responses.
• Support submission and approval processes in line with US/Canada requirements.
• Present regulatory information to cross-functional teams; train junior staff as needed.

Skills

Negotiation

Problem solving

Communication

Regulatory strategy

Cross-functional collaboration

Education

Advanced degree (PharmD/PhD/MS) or Regulatory certification

Job description

AbbVie in North Chicago, IL seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead to develop and implement regulatory strategy for US and Canada, ensuring alignment with GRPT and timely filings.

You will coordinate data for filings, respond to inquiries, manage registrations, and liaison with FDA, working cross-functionally with Clinical Development, Legal and Commercial to support commercialization.