Regulatory Strategy Lead, US & Canada

Regulatory Jobs; Florham Park (NJ); Hybride; USD 140 000 - 190 000; Plein temps

Résumé du poste

AbbVie is seeking a Senior Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to develop and implement regulatory strategies for on-market products or development programs, ensuring alignment with GRPT and regulatory guidelines.

The role interfaces with FDA, coordinates meeting packages, and leads cross-functional teams across Clinical, Legal, Public Affairs and Commercial to support filings, responses, and maintenance.

Qualifications

• Bachelor’s degree in a science field required.
• Minimum 6 years of regulatory affairs experience.
• Experience developing US & Canada regulatory strategies.
• Strong negotiation and communication skills.

Responsabilités

• Develop and execute regulatory strategies for US/Canada with cross-functional teams.
• Prepare and review regulatory submissions and responses to health authorities.
• Serve as liaison to FDA and coordinate meetings and briefing packages.
• Support submission/approval processes and regulatory maintenance.

Connaissances

Regulatory strategy

FDA liaison

Cross-functional leadership

Negotiation

Communication skills

Project management

Formation

Bachelor's degree in science

Description du poste

AbbVie is seeking a Senior Manager Regulatory Affairs, Global Regulatory Strategy US & Canada to develop and implement regulatory strategies for on-market products or development programs, ensuring alignment with GRPT and regulatory guidelines.

The role interfaces with FDA, coordinates meeting packages, and leads cross-functional teams across Clinical, Legal, Public Affairs and Commercial to support filings, responses, and maintenance.