Global Regulatory Strategy Director

Regulatory Jobs; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead (GRL I) within Global Regulatory Strategy to shape and implement global regulatory strategies for assigned products. The role leads the Global Regulatory Product Team (GRPT), coordinates with LRST and AST, and guides cross-functional teams through development and lifecycle regulation in a complex matrix environment.

The position requires extensive regulatory experience and leadership, with an emphasis on strategic planning and

Qualifications

• 5+ years of regulatory experience.
• 3+ years in a strategic leadership role.
• Experience interfacing with government regulatory agencies.
• Experience working in a complex, matrix environment.
• Drug development experience preferred.

Responsibilities

• Leads the Global Regulatory Product Team (GRPT) and develops global regulatory strategies.
• Interfaces with LRST and AST to implement cross-functional objectives.
• Ensures strategic messaging in global regulatory dossiers and responses to agency requests.
• Manages regulatory risk assessments and mitigation strategies for assigned products.
• Provides regulatory assessments and recommendations to executive management.

Skills

Regulatory strategy

Leadership

Cross-functional

Education

Bachelor's degree in life sciences

Advanced degree preferred

Certification a plus

Job description

AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead (GRL I) within Global Regulatory Strategy to shape and implement global regulatory strategies for assigned products. The role leads the Global Regulatory Product Team (GRPT), coordinates with LRST and AST, and guides cross-functional teams through development and lifecycle regulation in a complex matrix environment.

The position requires extensive regulatory experience and leadership, with an emphasis on strategic planning and