Senior Manager, Regulatory Affairs

A company is looking for a Senior Manager, Global Regulatory Affairs Labeling.

Key Responsibilities

Drives end-to-end labeling process and strategy for product lifecycle management and implementation across all markets

Facilitates cross-functional stakeholder review and consensus on proposed labeling content

Manages preparation of submission-ready labeling and artwork components, ensuring compliance with health authority requirements

Required Qualifications

BS in scientific discipline or equivalent preferred; advanced degree (MSc, PhD, PharmD, or JD) preferred but not required

7+ years of pharmaceutical industry experience, including approximately 5 years of pharmaceutical labeling experience

Detailed understanding of pharmaceutical drug development and global labeling regulations

Expertise in developing and maintaining Target Product Profiles (TPPs) and various labeling documents

Proficiency in labeling tools and systems for documentation, tracking, and compliance activities