Senior Regulatory Strategy Lead, US & Canada

Regulatory Jobs; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie's Regulatory Affairs group seeks a senior professional to develop and implement US/Canada regulatory strategies for on‑market and development programs. You will lead lifecycle activities, coordinate FDA communications, and advise cross‑functional teams on regulatory issues:

You will collaborate with GRPT and GRL, ensure timely submissions, and mentor junior staff to strengthen the regulatory capability across therapeutic areas.

Qualifications

• Advanced degree or regulatory certification with minimum 7 years of regulatory experience.
• Strong written and oral communication across Regulatory and cross-functional teams.
• Experience interfacing with government agencies and Health Authorities.

Responsibilities

• Develop and implement US/Canada regulatory strategic and tactical planning for assigned products.
• Lead lifecycle activities including product changes, post‑approval requirements and FDA interactions.
• Coordinate preparation of FDA briefing packages and regulatory submissions.
• Advise internal customers on Regulatory/FDA issues and maintain SME status.
• Mentor junior staff and contribute to regulatory training.

Skills

Regulatory strategy

Stakeholder management

Regulatory communications

Cross-functional collaboration

Negotiation

Education

Advanced degree (PharmD/PhD/MS) or Regulatory certification

Job description

AbbVie's Regulatory Affairs group seeks a senior professional to develop and implement US/Canada regulatory strategies for on‑market and development programs. You will lead lifecycle activities, coordinate FDA communications, and advise cross‑functional teams on regulatory issues:

You will collaborate with GRPT and GRL, ensure timely submissions, and mentor junior staff to strengthen the regulatory capability across therapeutic areas.