Global Regulatory Strategy Director - Lead & Impact

AbbVie Inc.; Irvine (CA); On-site; USD 182,000 - 346,000; Full time

Job summary

AbbVie Inc. is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) to develop and implement global strategies for market approvals and lifecycle management.

Leads the GRPT, interfaces with LRST and AST, and guides cross-functional teams through regulatory challenges. The role requires extensive regulatory expertise, strategic leadership, and the ability to manage complex programs across global regions, including US and CMC domains.

Qualifications

• Minimum 7+ years regulatory experience.
• Drug development knowledge in US&C region.
• Experience leading strategic regulatory initiatives.

Responsibilities

• Lead Global Regulatory Product Team to align strategies with regulations.
• Prepare and maintain global regulatory product strategies.
• Communicate regulatory assessments to executive management.
• Mentor GRPT members and drive cross-functional collaboration.

Skills

Strategic leadership

Cross-functional collaboration

Regulatory strategy

Project management

Education

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject

Advanced degree preferred

Regulatory certification a plus

Job description

AbbVie Inc. is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) to develop and implement global strategies for market approvals and lifecycle management.

Leads the GRPT, interfaces with LRST and AST, and guides cross-functional teams through regulatory challenges. The role requires extensive regulatory expertise, strategic leadership, and the ability to manage complex programs across global regions, including US and CMC domains.