Regulatory Strategy Lead, US & Canada

AbbVie; Illinois; Hybride; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits including PTO

Medical/dental/vision insurance

401(k) plan

Résumé du poste

AbbVie seeks a Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to lead regulatory planning for on-market and development-stage products. You will coordinate with Regulatory Staff, medical, legal and commercial teams to align filings with US and Canada guidelines.

The role requires 6 years of regulatory experience, strong communication, and negotiation skills. Hybrid work at AbbVie Lake County, IL is expected, with three days in the office.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related industry field.
• Advanced degree is a plus.
• 6 years of regulatory, R&D, or industry experience required.
• 2–3 years in pharmaceutical regulatory activities preferred.

Responsabilités

• Serve as Health Authority liaison with FDA for routine communications and filings.
• Contribute to development and execution of US and Canada regulatory strategy and submissions.
• Support regulatory submissions and timely responses to authorities; advise cross-functional teams.

Connaissances

Regulatory strategy

FDA liaison

Negotiation

Cross-functional teamwork

Communication

Formation

Bachelor’s degree in life sciences

Description du poste

AbbVie seeks a Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to lead regulatory planning for on-market and development-stage products. You will coordinate with Regulatory Staff, medical, legal and commercial teams to align filings with US and Canada guidelines.

The role requires 6 years of regulatory experience, strong communication, and negotiation skills. Hybrid work at AbbVie Lake County, IL is expected, with three days in the office.