Regulatory Affairs Associate – (YON920)

Global Responsibility

Support new regulatory submissions and assisting with the lifecycle management of the existing portfolio making sure that any variations and/or renewals will be submitted in time to ensure regulatory compliance.

Specific Responsibilities

• Support and provide the necessary documentation to local affiliates and clients for national submissions
• Support and provide the necessary documentation to local affiliates and clients to answer the LoDs with the aim to receive the MA as soon as possible
• Prepare the necessary documentation needed for submission of administrative/ quality and safety variations
• Submit renewals in a timely manner and ensure timelines are communicated with all partners
• Archiving of essential documents, such as product information and ensure the quality part of the dossier is archived and updated in line with company procedure
• Make sure that the essential information from the dossier post-approval is shared with implicated departments according to relevant procedures
• Make sure that the regulatory database is up to date for his/her projects in the region
• Stay up to date on the latest regulatory requirements in the region
• Inform interested parties, such as commercial, business development, and top management on the regulatory status in the respective area

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