Manager, Global Labeling Product Leader

Purpose

Global Labeling (GL) is a function within Global Regulatory Affairs accountable for the strategic development and lifecycle management of product labeling across therapeutic areas, established products, regions, and affiliates. The scope of Global Labeling covers the end-to-end labeling process throughout the product's lifecycle—from target labeling through the Company Core Data Sheet (CCDS), primary labeling documents (CCDS, USPI and associated patient labeling, EUPI), and derived labeling documents.

Responsibilities

• Leading the development, revision, review, agreement, and maintenance of primary labeling (CCDS, USPI and associated patient labeling, EUPI) and derived documents for assigned compounds.
• Making recommendations and providing advice and guidance about labeling content, processes, timelines, and scientific integrity.
• Coordinating the resolution of labeling issues with potential impact on primary or derived labeling or supporting documentation.
• Ensuring high quality and compliant labeling documents.
• Contributing to and participating in the global labeling strategy, including understanding competitors in the therapeutic area and their development plans and status.
• Contributing to the continuous improvement of the end-to-end labeling process.

Qualifications

• A minimum of Bachelor's degree in a scientific discipline is required.
• An advanced degree (MS, PhD, MD or PharmD) is preferred.
• A minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required.
• A minimum of 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent is preferred.
• An understanding of pharmaceutical drug development is required.
• Experience in discussing and communicating scientific concepts is required.
• Basic understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required.
• Experience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision is required.
• A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills is required.
• Experience working in document management systems is required.
• A successful track record of effectively prioritizing and managing multiple products and projects simultaneously is preferred.
• Demonstrated ability to drive a collaborative, customer-focused, learning culture is preferred.