Senior Manager, Global Regulatory Strategy - US & Canada

SmartRecruiters, Inc.; Irvine (CA); Hybrid; USD 125,000 - 237,000; Full time

Benefits offered by this job

Long-term incentive programs

Benefits package

Job summary

AbbVie seeks a Senior Manager Regulatory Affairs for US & Canada to lead regulatory strategy development and execution for on‑market and development products. You will ensure GRPT plans are implemented across teams to support filings and registrations.

This hybrid role demands strong negotiation and communication skills, plus 6+ years in regulatory affairs. You will interface with FDA, operate in a complex matrix, and contribute to global regulatory strategies.

Qualifications

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
• Advanced Degree a plus. Certifications a plus.
• Minimum of 6 years of experience in regulatory affairs, R&D, or related field, including 2–3 years of regulatory activities.
• Demonstrates negotiation skills and effective communication across Regulatory and organization.
• Global regulatory experience is a plus.

Responsibilities

• Develop and implement US and Canada regulatory strategies for assigned products.
• Act as HA liaison and interface with FDA for meetings and briefing packages.
• Independently negotiate and make decisions on project issues with crossfunctional impact.
• Prepare and review regulatory submissions for US and Canada; respond to Health Authorities.

Skills

Regulatory strategy

Negotiation

Communication

FDA liaison

Global regulatory

Education

Bachelor’s degree

Job description

AbbVie seeks a Senior Manager Regulatory Affairs for US & Canada to lead regulatory strategy development and execution for on‑market and development products. You will ensure GRPT plans are implemented across teams to support filings and registrations.

This hybrid role demands strong negotiation and communication skills, plus 6+ years in regulatory affairs. You will interface with FDA, operate in a complex matrix, and contribute to global regulatory strategies.