Strategic Regulatory Affairs Leader, US & Canada

ABBVIE; North Chicago (IL); Hybrid; USD 125,000 - 237,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) program

Long-term incentive programs

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs for Global Regulatory Strategy in US & Canada. The role drives regulatory strategy, coordinates with FDA, and ensures timely submissions to enable product commercialization. This position supports on-market and development programs with a hybrid work model.

Lake County, IL, Florham Park, NJ or Irvine, CA locations. The role requires a Bachelor’s degree in a relevant scientific field and at least 6 years in regulatory affairs, with strong

Qualifications

• Requires Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related field.
• Minimum 6 years of regulatory affairs experience in pharma/biotech.
• Experience interfacing with FDA and US/Canada regulatory authorities.

Responsibilities

• Develop and implement regulatory strategy for US & Canada.
• Serve as liaison to FDA and internal stakeholders.
• Lead preparation and submission of regulatory dossiers.
• Advise on regulatory risks and strategy within GRPT.
• Support regulatory submission and approvals across therapeutic areas.

Skills

Regulatory strategy

FDA liaison

Negotiation

Cross-functional collaboration

Education

Bachelor’s degree (pharmacy, biology, chemistry, pharmacology)

Advanced degree (preferred)

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs for Global Regulatory Strategy in US & Canada. The role drives regulatory strategy, coordinates with FDA, and ensures timely submissions to enable product commercialization. This position supports on-market and development programs with a hybrid work model.

Lake County, IL, Florham Park, NJ or Irvine, CA locations. The role requires a Bachelor’s degree in a relevant scientific field and at least 6 years in regulatory affairs, with strong