Global Regulatory Strategy Manager – US & Canada

BioSpace; North Chicago (IL); Hybrid; USD 120,000 - 180,000; Full time

Job summary

AbbVie, based in Lake County, IL, seeks a Manager Regulatory Affairs to develop and implement regulatory strategy for US & Canada and to support product filings. The role includes coordinating with FDA and other authorities, preparing submissions, and ensuring timely responses.

A seasoned professional with strong communication and negotiation skills is needed to navigate a complex regulatory environment. The position offers a hybrid work schedule and a comprehensive benefits package.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry or pharmacology, or equivalent industry experience.
• Advanced degree and certifications are a plus.
• 6 years in regulatory, R&D, or industry-related work.

Responsibilities

• Lead US and Canada regulatory strategy development and execution for assigned products.
• Act as Health Authority liaison with FDA for routine communications and responses.
• Prepare and review regulatory submissions and ensure timely responses to regulators.
• Support compliance with US & Canada regulations and guidelines.

Skills

Regulatory strategy

Regulatory submissions

Communication skills

Negotiation

Education

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

Advanced degree preferred

Certifications preferred

Job description

AbbVie, based in Lake County, IL, seeks a Manager Regulatory Affairs to develop and implement regulatory strategy for US & Canada and to support product filings. The role includes coordinating with FDA and other authorities, preparing submissions, and ensuring timely responses.

A seasoned professional with strong communication and negotiation skills is needed to navigate a complex regulatory environment. The position offers a hybrid work schedule and a comprehensive benefits package.