US & Canada Regulatory Strategy Lead: Neurotoxins

Allergan; Irvine (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins. This role directs regulatory strategy, planning, and execution for US & Canada, ensuring compliance with FDA requirements and global guidelines.

You will prepare regulatory submissions, coordinate inquiries, and serve as a regulatory expert for cross-functional teams across multiple therapeutic areas.

Qualifications

• Advanced degree or regulatory certification with 5+ years of regulatory/R&D experience.
• Experience negotiating regulatory issues and leading cross-functional projects.
• Excellent written and oral communication with regulatory bodies.

Responsibilities

• Develop and implement US & Canada regulatory strategy and tactical plans.
• Coordinate regulatory submissions and ensure timely responses to Health Authorities.
• Act as regulatory liaison with FDA and cross-functional teams across the enterprise.
• Provide guidance on regulatory implications and ensure alignment with GRPT.
• Mentor junior staff and support affiliate regulatory strategies.

Skills

Regulatory strategy

FDA liaison

Regulatory submissions

Cross-functional leadership

Negotiation

Education

Advanced degree (PharmD/PhD/MS)

Job description

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins. This role directs regulatory strategy, planning, and execution for US & Canada, ensuring compliance with FDA requirements and global guidelines.

You will prepare regulatory submissions, coordinate inquiries, and serve as a regulatory expert for cross-functional teams across multiple therapeutic areas.