Regulatory Labeling Manager – Lifecycle Products

About the role

The Regulatory Labeling Manager – Lifecycle Products is responsible for creating, maintaining, and overseeing labeling content for mature pharmaceutical products. You will ensure that all labeling reflects the latest safety information, regulatory requirements, and internal assessments while supporting the company’s compliance and governance processes.

Key responsibilities

• Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews.
• Author and revise labeling documents such as Company Core Data Sheets (CCDS), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest‑of‑World (ROW) labels.
• Support labeling governance by preparing materials, attending governance meetings, recording minutes, uploading documents to the electronic document management system, and obtaining required approvals.
• Ensure labeling content complies with applicable regulations (FDA, EMA, ICH) and internal standards.
• Collaborate with cross‑functional teams—including Safety, Medical, Legal, and Regulatory Strategy—to gather input and align on labeling changes.
• Assist in responding to health‑authority queries related to labeling.
• Partner with document specialists to maintain accurate and up‑to‑date labeling records.

Required profile

• Proven experience managing labeling for lifecycle pharmaceutical products.
• Strong knowledge of FDA, EMA, and ICH regulatory requirements.
• Ability to work effectively with cross‑functional stakeholders.
• Excellent documentation and governance skills.

Required skills

• Electronic Document Management System (EDM) proficiency.

What we offer

• Supportive, inclusive culture that encourages authentic self‑expression.
• Opportunities for career development, training, and progression.
• Total rewards program and peer recognition initiatives.