Senior Director, Global FDA Regulatory Strategy

Regulatory Jobs; North Chicago (IL); On-site; USD 260,000 - 380,000; Full time

Job summary

AbbVie in North Chicago seeks a Senior Director, Global Regulatory Strategy Lead and FDA Regulatory SME to oversee complex product development across therapeutic areas and provide FDA-specific expertise at the intersection of regulations, policy, and strategy.

You will lead global regulatory strategies to secure and maintain market approvals, manage US dossiers, mentor RA colleagues, and drive cross-functional initiatives with senior management.

Qualifications

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 15 years of regulatory experience.
• Proven leadership in a regulatory, R&D or equivalent role across therapeutic programs.
• Experience directing FDA regulatory policy interpretation and strategy.

Responsibilities

• Oversee complex product development across Therapeutic Areas with FDA SME input.
• Lead global regulatory strategies to secure and maintain market approvals.
• Manage US regulatory dossiers and cross-functional regulatory initiatives.
• Mentor RA colleagues and provide executive-level regulatory guidance.

Skills

Leadership

Regulatory strategy

FDA regulatory knowledge

Cross-functional collaboration

Communication

Education

Advanced degree in PharmD/PhD/MS

Job description

AbbVie in North Chicago seeks a Senior Director, Global Regulatory Strategy Lead and FDA Regulatory SME to oversee complex product development across therapeutic areas and provide FDA-specific expertise at the intersection of regulations, policy, and strategy.

You will lead global regulatory strategies to secure and maintain market approvals, manage US dossiers, mentor RA colleagues, and drive cross-functional initiatives with senior management.