Strategic Regulatory Affairs Lead - US & Canada (Hybrid)

Regulatory Jobs; Irvine (CA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) to lead regulatory strategic and tactical planning for on‑market products or development programs in the US and Canada.

You will coordinate with the Global Regulatory Lead Team, interface with FDA for meetings, prepare briefing packages, and align cross‑functional teams to ensure compliant, timely regulatory submissions and approvals across therapeutic areas.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related field.
• 6 years regulatory, R&D, or industry-related experience.
• Experience in a complex, matrix environment.
• Experience interfacing with government regulatory agencies.

Responsibilities

• Develop and implement regulatory strategy for US & Canada within on-market products or development programs.
• Serve as HA liaison and interact with FDA for meetings and briefing packages.
• Advise internal customers on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and Commercial.
• Prepare and review regulatory submissions ensuring compliance with US/Canada requirements.
• Train and mentor staff; contribute to documentation and submission processes.

Skills

Negotiation skills

Problem solving

Communication skills

Stakeholder management

Education

Bachelor’s degree

Job description

AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) to lead regulatory strategic and tactical planning for on‑market products or development programs in the US and Canada.

You will coordinate with the Global Regulatory Lead Team, interface with FDA for meetings, prepare briefing packages, and align cross‑functional teams to ensure compliant, timely regulatory submissions and approvals across therapeutic areas.