MSD EU Labeling Lead Associate Director 

United Kingdom, England, London 

157843990

Job Description

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.

Closing date for applications: 16/02/2025

Current Contingent Workers apply

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