EU Labeling Lead, Associate Director

EU Labeling Lead Associate Director

Job Description

General Summary

The purpose of Global Labeling is to drive labeling strategy and ensure high quality and compliant labeling documents which ensures the safe and effective use of products for patients and healthcare providers, globally. As part of Global Labeling, and under the supervision of the EU Labeling Group Lead, the EU Labeling Lead Associate Director is responsible for managing the labeling of developmental and marketed products registered under EU procedures (MRP/DCP/CP).This includes collaboration with the cross-functional labeling team to develop and maintain the EU Product Information (including all its Annexes as defined by EU legislation).

Responsibilities of the EU Labeling Lead Associate Director may include, but are not limited to:

• Manages the updates of the English EU PI (SmPC, Annex II, labeling, package leaflet and other applicable annexes) in collaboration with the Regulatory Affairs Europe team.
• Ensures that the EU PI adheres to regulatory template/format of EU PI and provides subject matter expertise on associated guidelines and guidance documents including Quality Review of Documents (QRD), in line with industry best practices.
• Oversees change control for EU labeling documents.
• Oversees the labeling activities of a team of EU Labeling Lead Senior Specialists
• Oversees the monitoring for competitor labeling updates.
• Ensures the appropriate review and analyses of labeling guidelines and regulations to ensure conformance with EU regulations.
• Oversees, understands, and interprets complex scientific issues as it relates to regulatory requirements and labeling strategy.
• Proactively identifies labeling issues. Offers creative solutions and strategies, including risk mitigation strategies.
• Participates in continuous improvement projects for EU labeling activities and business objectives. Initiates and/or implements procedures, processes, or programs to align with corporate strategies and processes.
• Ensures adequate support in compliance initiatives

Skills

• Highly experienced knowledge and understanding of the scientific principles of the drug development process
• Specialized knowledge of regulations pertaining to drug product labeling. Experience in Oncology
• Good oral and written communication and presentation skills
• Process improvement or compliance/quality experience.
• Good negotiation skills.
• Ability to develop relationships and work well with others even in demanding situations with a positive attitude.
• Ability to interact with cross-functional team remotely located
• Detail oriented, well organized
• High project management skills
• Experience in Word, Excel and PowerPoint, and document management tools.

Education

• Bachelor’s degree in a scientific or medically related discipline required. Master’s degree preferred
• Extensive pharmaceutical or relevant experience with a focus on EU regulatory product labeling requirements for marketed and developmental products.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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