Global Regulatory Strategy Lead, US & Canada (Hybrid)

Regulatory Jobs; South San Francisco (CA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy for on-market and development programs in a hybrid work model. You will coordinate with FDA, support submissions, and ensure alignment with regulatory strategy across teams.

The ideal candidate holds a relevant bachelor's degree and has at least 6 years of regulatory experience, including exposure to global regulatory activities.

Qualifications

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

Responsibilities

• Develop and implement US and Canada regulatory strategic and tactical planning for on-market products or development.
• Coordinate FDA meetings, briefing packages, and responses.
• Advise internal customers on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others.
• Prepare and review regulatory submissions consistent with US and Canada requirements.
• Support the regulatory submission and approval process.
• Operate in compliance with regulations, company policies, and QDP.

Skills

Negotiation skills

Problem solving

Communication skills

Consensus building

Education

Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy for on-market and development programs in a hybrid work model. You will coordinate with FDA, support submissions, and ensure alignment with regulatory strategy across teams.

The ideal candidate holds a relevant bachelor's degree and has at least 6 years of regulatory experience, including exposure to global regulatory activities.