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01/09/2024

ALBEDIS

Regulatory Affairs Specialist (1-Year Contract)

  • ALBEDIS

  • 1204Geneva

  • 01/09/2024

  • Emploi permanent 100%

Emploi permanent 100%

1204Geneva

DESCRIPTION DE LA MISSION: As the Regulatory Affairs Specialist, you will play a critical role in enabling the PHC business for the relevant portfolio within and outside Europe. You will coordinate Regulatory Life Cycle Management activities across multiple countries, ensuring compliance with regulatory requirements and maintaining Global Master Dossiers. Additionally, you will provide strategic input into Regional Product labeling and approval to facilitate commercial activation of product launches.Your key responsibilities will be:To build medicinal capability within Regulatory Affairs Life Cycle Management and ensure medicinal aspects are integrated into projects, work processes, and systems.To coordinate changes to existing products/dossiers to maintain market presence and compliance.To act as the primary point of contact for local regulatory colleagues, fostering effective communication and collaboration.To maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance.To advise the organization on potential regulatory risks and recommend compliant actions.To ensure regulatory assessments are conducted for change controls in the Veeva Quality Tracking system.To maintain and update the Veeva Regulatory Information Management system for all activities under role responsibility.To contribute to new regulatory policies, systems, and processes to reinforce governance and compliance across LCM and the Regulatory Affairs function.
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