Global Regulatory Strategy Lead - US & Canada

SmartRecruiters, Inc.; Florham Park (NJ); Hybrid; USD 125,000 - 237,000; Full time

Job summary

AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada. You will develop and implement strategic and tactical plans for US and Canada regulatory compliance, ensuring alignment with the GRPT and business needs.

You will interface with FDA, prepare briefing packages, and coordinate regulatory submissions and responses. The role requires cross-functional collaboration and strong negotiation skills within a hybrid work model.

Qualifications

• Required: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or equivalent.
• Minimum of 6 years in regulatory affairs, R&D, or related pharmaceutical field, with 2–3 years in pharmaceutical regulatory activities.
• Strong negotiation, communication, and cross-functional collaboration skills.

Responsibilities

• Develop and implement US and Canada regulatory strategy (RSTP) for assigned products.
• Interface with FDA and coordinate briefing packages, responses, and meetings.
• Support regulatory submissions and responses to Health Authorities in US/Canada.
• Lead regulatory strategy execution in a complex, matrix environment.
• Contribute to regulatory strategy and guidance within the organization.

Skills

Regulatory strategy

FDA liaison

Regulatory submissions

Health Authority interaction

Education

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

Job description

AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada. You will develop and implement strategic and tactical plans for US and Canada regulatory compliance, ensuring alignment with the GRPT and business needs.

You will interface with FDA, prepare briefing packages, and coordinate regulatory submissions and responses. The role requires cross-functional collaboration and strong negotiation skills within a hybrid work model.