Global Regulatory Strategy Lead – US & Canada (Hybrid)

Regulatory Jobs; North Chicago (IL); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) and long-term incentives

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs for Global Reg Strategy US & Canada. You will develop regulatory strategies, coordinate FDA activities, and lead submissions for on-market and development programs.

The role requires strong negotiation, cross-functional collaboration, and deep regulatory knowledge in US/Canada. The position offers a hybrid work model with locations in Lake County, IL, Florham Park NJ or Irvine CA, and a comprehensive benefits package.

Qualifications

• Minimum of 6 years of regulatory affairs experience in pharma/biotech.
• Experience coordinating Regulatory Strategy for US & Canada.
• Strong negotiation and cross-functional collaboration skills.

Responsibilities

• Develop and implement US/Canada regulatory strategies.
• Interface with FDA for meetings, prepare briefing packages and responses.
• Lead regulatory submissions and ensure timely responses to Health Authorities.
• Provide regulatory guidance to cross-functional teams (Clinical, Legal, Commercial).
• Contribute to training and mentoring of staff on regulatory processes.
• Ensure compliance with regulatory product strategy and QDP.

Skills

Regulatory strategy

Regulatory submissions

FDA liaison

Negotiation skills

Effective communication

Education

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

Advanced degree preferred

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs for Global Reg Strategy US & Canada. You will develop regulatory strategies, coordinate FDA activities, and lead submissions for on-market and development programs.

The role requires strong negotiation, cross-functional collaboration, and deep regulatory knowledge in US/Canada. The position offers a hybrid work model with locations in Lake County, IL, Florham Park NJ or Irvine CA, and a comprehensive benefits package.