Hybrid Global Regulatory Strategy Manager - US & Canada

AbbVie Inc.; Chicago (IL); Hybride; USD 140 000 - 210 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Paid time off

Medical/dental/vision insurance

Résumé du poste

AbbVie Inc. seeks a Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to lead regulatory strategy for US and Canada, support filings, and coordinate cross-functional teams toward timely approvals.

The role involves acting as FDA liaison, preparing submissions, and applying knowledge of regulatory guidelines across therapeutic areas. A hybrid schedule with 3 days in-office at the Lake County, IL headquarters is required.

Qualifications

• Proven skill at implementing US and Canada regulatory strategies.
• Experience in a complex, matrix work environment.
• Excellent oral and written communication.
• Experience interfacing with government regulatory agencies.
• Strong negotiation skills and ability to build consensus.

Responsabilités

• Serve as Health Authority liaison with FDA for routine filings.
• Prepare and review regulatory submissions for US/Canada.
• Support regulatory submission and approval processes.
• Provide regulatory guidance to cross-functional teams.
• Align with regulatory product strategy and QDP.
• Meet the hybrid work requirement at AbbVie Lake County, IL.

Connaissances

Regulatory strategy

Matrix environment

Communication

Regulatory agencies

Negotiation

Formation

Bachelor’s degree in life sciences or pharmacy

Advanced degree

Description du poste

AbbVie Inc. seeks a Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to lead regulatory strategy for US and Canada, support filings, and coordinate cross-functional teams toward timely approvals.

The role involves acting as FDA liaison, preparing submissions, and applying knowledge of regulatory guidelines across therapeutic areas. A hybrid schedule with 3 days in-office at the Lake County, IL headquarters is required.