Strategic Regulatory Lead, US & Canada — Senior Manager

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

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Cambridge, MA, seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead. The role leads regulatory strategy for US/Canada, interfaces with FDA, and coordinates submissions to enable timely product approvals. Hybrid work arrangement available.

The role requires an advanced degree or regulatory certification and 5+ years in regulatory/R&D, with strong negotiation and communication capabilities across functions.

Qualifications

• Advanced degree or regulatory certification with 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Demonstrates excellent negotiation skills and effective communication across Regulatory and the organization

Responsibilities

• Serve as Health Authority liaison and interface with FDA for meetings and briefing packages.
• Develop and implement US and Canada regulatory strategies per GRPT guidance.
• Prepare and review regulatory submissions consistent with US/Canada requirements.
• Advise internal customers on Regulatory/FDA issues including Public Affairs and Legal.
• Ensure timely responses to Health Authorities during application reviews.

Skills

Regulatory strategy

FDA liaison

Cross-functional

Negotiation

Communication

Matrix experience

Education

Advanced degree or regulatory certification

Job description

AbbVie in Cambridge, MA, seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead. The role leads regulatory strategy for US/Canada, interfaces with FDA, and coordinates submissions to enable timely product approvals. Hybrid work arrangement available.

The role requires an advanced degree or regulatory certification and 5+ years in regulatory/R&D, with strong negotiation and communication capabilities across functions.