Strategic Regulatory Affairs Lead, US & Canada (Hybrid)

AbbVie Inc.; Florham Park (NJ); Hybrid; USD 140,000 - 185,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie Inc. is seeking a Senior Manager Regulatory Affairs for Global Reg Strategy in the US & Canada. The role drives regulatory strategy and tactical planning for on-market and development products, coordinating with FDA and cross-functional teams to support filings and approvals.

The position emphasizes extensive regulatory experience, strong negotiation and communication skills, and the ability to work within a complex matrix environment. Hybrid work is available at multiple U.S.

Qualifications

• Bachelor’s degree in a life sciences field or related industry experience.
• Advanced degree or certifications are a plus.
• Minimum 6 years in regulatory affairs, R&D, or related pharma field, incl. 2–3 years in regulatory activities.

Responsibilities

• Responsible for regulatory strategy development and execution for US & Canada.
• Interfaces with FDA for meetings and briefing packages; advises internal customers on Regulatory/FDA issues.
• Works independently on project-related issues with cross-functional impact.
• Prepares and reviews regulatory submissions in US & Canada; ensures timely responses to Health Authorities.
• Supports regulatory submission and approval processes; applies knowledge of regulations, guidances, and corporate policies.
• Presents regulatory information to cross-functional areas; ensures compliance with QDP.
• Works in a hybrid model (3 days in office, 2 days remote) from AbbVie locations.

Skills

Regulatory strategy

Negotiation

Effective communication

Cross-functional collaboration

FDA liaison

Global regulatory

Education

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

Advanced degree a plus

Job description

AbbVie Inc. is seeking a Senior Manager Regulatory Affairs for Global Reg Strategy in the US & Canada. The role drives regulatory strategy and tactical planning for on-market and development products, coordinating with FDA and cross-functional teams to support filings and approvals.

The position emphasizes extensive regulatory experience, strong negotiation and communication skills, and the ability to work within a complex matrix environment. Hybrid work is available at multiple U.S.