Regulatory Strategy Lead – US & Canada (Global RA)

AbbVie; Cambridge (MA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) plan

Paid time off

Job summary

AbbVie's Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada, is responsible for developing and implementing regulatory strategy for US and Canada, ensuring alignment with GRPT and regulatory requirements. The role interfaces with FDA and coordinates submissions and inquiries to enable product commercialization.

The position requires a minimum of 6 years in regulatory affairs with strong negotiation and communication skills, and offers a hybrid work schedule across multiple U.S.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related field.
• 6+ years in regulatory affairs or related pharma field; 2–3 years in regulatory activities.
• Strong negotiation, communication, and cross-functional collaboration skills.

Responsibilities

• Lead US/Canada regulatory strategy development and execution.
• Interface with FDA and prepare briefing packages and responses.
• Support regulatory submissions and health authority interactions.

Skills

Negotiation skills

Communication skills

Cross-functional collaboration

Regulatory strategy

Education

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

Job description

AbbVie's Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada, is responsible for developing and implementing regulatory strategy for US and Canada, ensuring alignment with GRPT and regulatory requirements. The role interfaces with FDA and coordinates submissions and inquiries to enable product commercialization.

The position requires a minimum of 6 years in regulatory affairs with strong negotiation and communication skills, and offers a hybrid work schedule across multiple U.S.