Hybrid Global Regulatory Strategy Manager, US & Canada

AbbVie Inc.; North Chicago (IL); Hybrid; USD 120,000 - 165,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Long-term incentive programs

Job summary

AbbVie Inc. in Lake County, IL is seeking a Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to lead regulatory planning for US and Canada markets and to align strategy with development and commercialization goals.

You will act as a primary FDA liaison, prepare and review regulatory submissions, advise cross-functional teams, and ensure timely, compliant interactions with health authorities across the lifecycle of assigned products.

Qualifications

• 6 years Regulatory, R&D, or Industry-related experience.
• 2-3 years in pharmaceutical regulatory activities.
• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
• Advanced degree or certifications a plus.

Responsibilities

• Serve as Health Authority liaison with FDA for routine communications in support of filings.
• Support preparation and review of regulatory submissions compliant with US/Canada requirements.
• Provide regulatory guidance to cross-functional teams including Clinical, Legal and Commercial.
• Apply regulatory knowledge to advise on project strategy and approvals.

Skills

Regulatory strategy

FDA liaison

Cross-functional collaboration

Regulatory submissions

Regulatory compliance

Education

Bachelor’s degree in pharmacy/biology/chemistry/pharmacology or industry related

Job description

AbbVie Inc. in Lake County, IL is seeking a Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to lead regulatory planning for US and Canada markets and to align strategy with development and commercialization goals.

You will act as a primary FDA liaison, prepare and review regulatory submissions, advise cross-functional teams, and ensure timely, compliant interactions with health authorities across the lifecycle of assigned products.