Global Regulatory Lead, Oncology Early Development

Regulatory Jobs; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks a Regulatory Affairs Director to join its global team, leading global regulatory strategies for multiple oncology assets across development stages in a large pharmaceutical company.

You will guide submissions, coordinate with cross-functional teams, and interface with Health Authorities to ensure compliant, timely advancement of programs in a dynamic, biotech-like environment.

Qualifications

• Requires Bachelor degree in life sciences, chemistry, or related discipline.
• Advanced degree preferred; certification a plus.

Responsibilities

• Serve as Global Regulatory Lead on project teams and sub-teams.
• Develop and implement global regulatory strategies for oncology products (clinical, nonclinical, CMC).
• Provide guidance on interpretation of regulatory requirements and review processes.
• Collaborate with regional affiliates to support ex-US development activities.
• Lead regulatory meetings with Health Authorities and manage regulatory documentation submissions.

Skills

Regulatory leadership

Global regulatory strategy

Project management

Cross-functional collaboration

Regulatory affairs

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie seeks a Regulatory Affairs Director to join its global team, leading global regulatory strategies for multiple oncology assets across development stages in a large pharmaceutical company.

You will guide submissions, coordinate with cross-functional teams, and interface with Health Authorities to ensure compliant, timely advancement of programs in a dynamic, biotech-like environment.