Senior Regulatory Strategy Lead – US & Canada

AbbVie; North Chicago (IL); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

Long-term incentives

Job summary

AbbVie is seeking an experienced Regulatory professional to lead US/Canada regulatory strategy and lifecycle activities for on-market and development products. You will coordinate submissions, interface with FDA, and guide cross-functional teams to ensure compliant, timely regulatory outcomes.

You will collaborate with Global Regulatory Product Teams, manage complex regulatory projects in a matrix environment, and mentor junior staff while contributing to strategic decisions across therapeutic

Qualifications

• Advanced degree or regulatory certification required.
• Strong written and verbal communication skills across Regulatory and cross-functional teams.
• Extensive experience interfacing with government agencies and Health Authorities.

Responsibilities

• Lead regulatory strategy development and lifecycle activities for US/Canada products.
• Coordinate and review regulatory submissions and ensure timely responses to Health Authorities.
• Manage interface with FDA and coordinate briefings and meetings.
• Mentor and develop junior staff within the Regulatory team.
• Provide SME input on regulatory strategy and cross-functional projects.

Skills

Regulatory strategy

FDA interactions

Regulatory submissions

Communication

Negotiation

Matrix environment

Education

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

Job description

AbbVie is seeking an experienced Regulatory professional to lead US/Canada regulatory strategy and lifecycle activities for on-market and development products. You will coordinate submissions, interface with FDA, and guide cross-functional teams to ensure compliant, timely regulatory outcomes.

You will collaborate with Global Regulatory Product Teams, manage complex regulatory projects in a matrix environment, and mentor junior staff while contributing to strategic decisions across therapeutic