Global Regulatory Strategy Lead, US & Canada

AbbVie; Florham Park (NJ); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie in Florham Park, NJ seeks a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy. You will develop and implement plans, coordinate FDA interactions, and guide submissions across therapeutic areas. Hybrid schedule with in-office and remote days.

The role requires 6+ years in regulatory affairs, a science degree, and strong negotiation and communication skills to align with complex cross-functional teams.

Qualifications

• Bachelor’s degree in a related science field or industry equivalent.
• Advanced degree is a plus; certifications are advantageous.
• Minimum regulatory affairs experience with pharmaceutical products.

Responsibilities

• Develop and implement regulatory strategies for US and Canada.
• Coordinate with FDA and cross-functional teams on submissions.
• Prepare and review regulatory submissions and responses to Health Authorities.

Skills

Regulatory affairs

Negotiation skills

Communication skills

Education

Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related

Advanced degree (preferred)

Certifications a plus

Job description

AbbVie in Florham Park, NJ seeks a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy. You will develop and implement plans, coordinate FDA interactions, and guide submissions across therapeutic areas. Hybrid schedule with in-office and remote days.

The role requires 6+ years in regulatory affairs, a science degree, and strong negotiation and communication skills to align with complex cross-functional teams.