GLOBAL REGULATORY AFFAIRS LABELLING MANAGER, REMOTE

Posting Date: 03.01.2024

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We are looking for a Global Regulatory Affairs Manager – Labelling, to join a major CRO. This is a permanent role that can be based either remotely (from certain European locations) or on hybrid basis.

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Our client is a global Clinical Research Organization.

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This position will be leading the development, review and management of EU, US and international labelling for early-stage drug candidates as well as commercial products for key CRO clients. The Global Labelling Manager will be responsible for assessing and managing labelling changes, communicating labelling strategies to project teams, ensuring the labelling is accurate and of the highest quality, while staying compliant with EU, US and international regulations.

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Responsibilities:

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• Close collaboration with subject matter experts, regulatory sub-teams and senior management to ensure the execution of global regulatory labelling plans and strategies.

• Support global regulatory affairs strategists to ensure labelling compliance between Company Core Data Sheets and local PIs.

• Project manage logistical activities and deliver labelling documents within agreed timelines.

• Preparation of labelling content based on source documents and other reference documents.

• Maintain knowledge of current rules and regulations governing global labelling activities.

• Reviewing and approval of artwork and change control related to labelling activities.

• Provide input on the interpretation and implementation of key regional and international labelling guidelines, regulations and practices.

• Lead labelling data management in the regulatory information management system – maintaining related data and monitoring E2E labelling process, ensuring PhV inspection readiness.

• Provide regulatory input to PSURS and annual reports for assigned products. Review final artworks, change requests and approve new or revised labelling to be implemented into production.

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Knowledge and experience needed:

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• Minimum requirement of BS or MS degree or advanced degree in a scientific field.

• 5 years of Regulatory Affairs experience managing labelling submissions and related activities.

• US and/or EU labelling experience required, and end-to-end global labelling processes knowledge needed.

• Working knowledge of SPL and PLR requirements, SPC/PIL and QRD requirements.

• Excellent writing skills and proven experience in drafting labelling content and presentation skills. Working knowledge of medical terminology and drug safety.

• Fluency in English with strong verbal and communication skills.

• Highly organized with the ability to manage complex projects and timelines.

• Strong attention to details required, critical thinking and the ability to work independently as well as part of a team.

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If you are looking for your next career step in the new year, this may be the opportunity you have been waiting for. Get in touch for more information on the company and the role. Send us your CV or click on the apply button to register your interest.

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