Global Regulatory Strategy Lead (US & Canada) - Hybrid

AbbVie; North Chicago (IL); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Long-term incentive programs

Job summary

AbbVie in the Lake County IL area seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead regulatory strategy and tactical planning for US and Canada products. You’ll coordinate FDA interactions, prepare submissions, and ensure timely responses to authorities while guiding cross-functional teams.

The role operates on a hybrid schedule (3 days in office, 2 days remote) with a strong emphasis on collaboration across global teams and senior stakeholders.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry or pharmacology or related field.
• Advanced degree a plus and regulatory certification a plus.
• Minimum 6 years in regulatory affairs or related field.
• Proven negotiation and cross-functional collaboration skills.
• Strong written and oral communication within Regulatory and across the organization.

Responsibilities

• Develop and execute regulatory strategies for US & Canada.
• Serve as liaison with FDA, coordinate meetings and briefing packages.
• Prepare and review regulatory submissions in line with US/Canada requirements.
• Support regulatory submission and approval processes and respond to Health Authorities.
• Provide regulatory guidance to cross-functional teams and train staff.

Skills

Regulatory strategy

FDA meetings coordination

Regulatory submissions

Cross-functional collaboration

Negotiation skills

Communication skills

Education

Bachelor's degree in pharmacy/biology/chemistry/pharmacology

Advanced degree a plus

Job description

AbbVie in the Lake County IL area seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead regulatory strategy and tactical planning for US and Canada products. You’ll coordinate FDA interactions, prepare submissions, and ensure timely responses to authorities while guiding cross-functional teams.

The role operates on a hybrid schedule (3 days in office, 2 days remote) with a strong emphasis on collaboration across global teams and senior stakeholders.