Regulatory Strategy Manager, US & Canada (Hybrid)

Regulatory Jobs; Chicago (IL); Hybrid; USD 120,000 - 180,000; Full time

Job summary

AbbVie in Lake County, IL is seeking a Manager Regulatory Affairs to lead US & Canada regulatory strategy for on-market products and development programs. The role focuses on planning, data collection, and timely interactions with Health Authorities to support filings and registrations.

You will negotiate with FDA, coordinate cross-functional teams, and ensure submissions meet regulatory guidelines. Hybrid work includes 3 days in office; we seek candidates with 6 years of regulatory or related

Qualifications

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
• Advanced Degree a plus. Certifications a plus.
• Required Experience: 6 years Regulatory, R&D, or Industry-related experience.
• Preferred Experience: 2-3 years in pharmaceutical regulatory activities.
• Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus.
• Experience working in a complex and matrix environment.
• Good communication, both oral and written.
• Experience interfacing with government regulatory agencies.
• Demonstrates good negotiation skills and builds consensus.

Responsibilities

• Develop and execute regulatory strategy for US and Canada.
• Serve as Health Authority liaison with FDA for routine communications.
• Prepare and review regulatory submissions in US/Canada.
• Support regulatory submission and approval processes.
• Apply regulatory knowledge to projects and cross-functional teams.
• Present regulatory information to cross-functional areas.
• Ensure compliance with regulations and the Quality Dossier Program (QDP).

Education

Bachelor’s degree (pharmacy, biology, chemistry, pharmacology)

Advanced Degree

Good communication

Negotiation skills

Interfacing with government regulatory agencies

Job description

AbbVie in Lake County, IL is seeking a Manager Regulatory Affairs to lead US & Canada regulatory strategy for on-market products and development programs. The role focuses on planning, data collection, and timely interactions with Health Authorities to support filings and registrations.

You will negotiate with FDA, coordinate cross-functional teams, and ensure submissions meet regulatory guidelines. Hybrid work includes 3 days in office; we seek candidates with 6 years of regulatory or related