Global Regulatory Strategy Lead – US & Canada

AbbVie Inc.; Cambridge (MA); Hybrid; USD 125,000 - 237,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision insurance

401(k) plan

Job summary

AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs to lead regulatory strategy for US & Canada, ensuring alignment with GRPT and business needs.

You will gather data to support filings and enable commercialization while liaising with Health Authorities and cross-functional teams. The role requires extensive regulatory experience, strong negotiation skills, and the ability to operate in a matrix environment across multiple locations, including Cambridge, MA, and other US

Qualifications

• Minimum 6 years of experience in regulatory affairs, R&D or related pharmaceutical field.
• At least 2–3 years performing pharmaceutical regulatory activities.
• Experience interfacing with FDA and other health authorities.
• Strong negotiation and communication skills, both written and oral.
• Ability to work effectively in a complex, matrix environment.

Responsibilities

• Develop and implement US and Canada regulatory strategy and tactical planning for assigned products.
• Serve as Health Authority liaison and coordinate FDA meetings and briefing packages.
• Prepare, review and submit regulatory submissions; ensure timely responses to inquiries.
• Support regulatory submission and approval processes with regulatory knowledge across therapeutic areas.
• Collaborate across Regulatory, Legal, Clinical, and Commercial teams to align strategies.

Skills

Regulatory affairs

Stakeholder communication

Negotiation

Education

Bachelor’s degree in pharmacy/biology/chemistry/pharmacology

Advanced degree (preferred)

Job description

AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs to lead regulatory strategy for US & Canada, ensuring alignment with GRPT and business needs.

You will gather data to support filings and enable commercialization while liaising with Health Authorities and cross-functional teams. The role requires extensive regulatory experience, strong negotiation skills, and the ability to operate in a matrix environment across multiple locations, including Cambridge, MA, and other US