Labelling Specialist EU/RoW (mwd)

Proclinical is seeking a Labelling Specialist EU/RoW to support regulatory affairs activities in the dermatology and pharmaceutical sectors. This role focuses on managing labeling processes, ensuring compliance with local and international requirements, and collaborating with cross-functional teams to meet launch timelines.

Responsibilities:

• Coordinate translations of core labeling data and manage these translations within the labeling database.
• Oversee validation processes, including corrections and approvals of language versions by local regulatory experts, and update the labeling database accordingly.
• Ensure regulatory compliance of labeling materials for medical devices by coordinating requirements from various departments such as Paralegal, Quality, and Marketing.
• Collaborate with Supply Chain Planning and other departments to ensure timely technical release and ready-to-print labeling materials aligned with packaging and launch schedules.
• Maintain accurate and up-to-date product information texts within the content management database (ST4).

Key Skills and Requirements:

• Strong organizational and coordination skills to manage labeling translations and validations effectively.
• Familiarity with regulatory aspects of labeling components, particularly for medical devices.
• Ability to work collaboratively with cross-functional teams to meet project deadlines.
• Proficiency in maintaining and updating content management databases, such as ST4.
• Attention to detail to ensure compliance with local labeling requirements and accuracy in documentation.

If you are having difficulty in applying or if you have any questions, please contact Fidan Beqiraj at f.beqiraj@proclinical.com.

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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