Regulatory Strategy Lead: US & Canada (Hybrid)

Allergan; Irvine (CA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs for Global Regulatory Strategy US & Canada in a hybrid role. You will lead the development and execution of regulatory strategies, coordinate with FDA and health authorities, and drive successful submissions for products in development or on market.

The role requires deep regulatory expertise in US/Canada, strong cross-functional collaboration, and the ability to navigate complex regulatory environments.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related field.
• 6 years Regulatory, R&D, or Industry-related experience.
• Experience in complex, matrix environments and interfacing with regulatory agencies.

Responsibilities

• Develop and implement US/Canada regulatory strategy and tactics.
• Interface with FDA and regulatory authorities to support submissions.
• Prepare and maintain regulatory submissions and responses to inquiries.
• Advise cross-functional teams on Regulatory/FDA issues including Public Affairs, Legal and Clinical Development.
• Lead training and mentorship for staff on regulatory processes.
• Ensure regulatory submissions meet US and Canada requirements and deadlines.

Skills

Negotiation

Problem solving

Communication

Regulatory strategy

Education

Bachelor’s degree in life sciences

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs for Global Regulatory Strategy US & Canada in a hybrid role. You will lead the development and execution of regulatory strategies, coordinate with FDA and health authorities, and drive successful submissions for products in development or on market.

The role requires deep regulatory expertise in US/Canada, strong cross-functional collaboration, and the ability to navigate complex regulatory environments.