Global Regulatory Strategy Lead, US & Canada

Regulatory Jobs; Cambridge (MA); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs to lead Global Regulatory Strategy for US & Canada. You will shape regulatory plans for on-market and development products and ensure compliance with US/Canada requirements, coordinating with global teams.

You will liaison with FDA, prepare briefing packages, and guide cross-functional teams while mentoring staff. Hybrid schedule with multi-locations available.

Qualifications

• Bachelor’s degree required in relevant field.
• Minimum of 6 years in regulatory affairs or related field.
• Experience with US FDA interactions and filings.

Responsibilities

• Develop and execute regulatory strategies for US/Canada.
• Assist in development and execution of regulatory plans for assigned products.
• Lead cross-functional coordination and mentorship within the team.
• Prepare regulatory submissions and timely responses to health authorities.
• Ensure compliance with US/Canada regulations and GRPT/Quality Dossier Program.

Skills

Regulatory strategy development

FDA interactions

Cross-functional leadership

Regulatory submissions

Negotiation

Education

Bachelor’s degree in Pharmacy/Biology/Chemistry/Pharmacology

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs to lead Global Regulatory Strategy for US & Canada. You will shape regulatory plans for on-market and development products and ensure compliance with US/Canada requirements, coordinating with global teams.

You will liaison with FDA, prepare briefing packages, and guide cross-functional teams while mentoring staff. Hybrid schedule with multi-locations available.