US & Canada Regulatory Strategy Lead - Associate Director

Regulatory Jobs; Irvine (CA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Irvine, CA is seeking an experienced Senior Regulatory Affairs professional to lead US/Canada regulatory strategy and tactical planning for on-market and development programs.

You will partner with Global Regulatory Lead, manage FDA interactions, oversee regulatory submissions, and guide lifecycle activities while mentoring junior staff. This role demands strategic thinking and strong cross-functional collaboration.

Qualifications

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 7 years Regulatory, R&D, or equivalent industry-related experience.
• Effective communication skills in written and oral channels both within Regulatory and across the organization.
• Extensive experience interfacing with government Agencies and Health Authority personnel.
• Ability to deliver challenging messages without compromising business relationships.
• Experience in a complex, matrixed environment.

Responsibilities

• Leads total product lifecycle activities, including product/manufacturing change assessments and post-approval requirements.
• Manages interface with Health Authority (FDA) for key projects and coordinates FDA briefing packages.
• Advises internal customers on Regulatory/FDA issues across functions.
• Coordinates preparation and review of regulatory submissions for US/Canada.
• Presents regulatory information to cross-functional teams and oversees regulatory strategy execution.

Skills

Regulatory strategy

FDA interface

Regulatory submissions

Cross-functional leadership

Communication

Education

Advanced degree in PharmD/PhD/MS or Regulatory certification

Job description

AbbVie in Irvine, CA is seeking an experienced Senior Regulatory Affairs professional to lead US/Canada regulatory strategy and tactical planning for on-market and development programs.

You will partner with Global Regulatory Lead, manage FDA interactions, oversee regulatory submissions, and guide lifecycle activities while mentoring junior staff. This role demands strategic thinking and strong cross-functional collaboration.