Regulatory Affairs Associate - (Dlk-133)

Global Responsibility Support new regulatory submissions and assist with the lifecycle management of the existing portfolio, ensuring that any variations and/or renewals are submitted in time to maintain regulatory compliance.
Specific Responsibilities Support and provide the necessary documentation to local affiliates and clients for national submissions.
Assist local affiliates and clients in answering the LoDs to expedite the receipt of the MA.
Prepare the necessary documentation needed for submission of administrative, quality, and safety variations.
Submit renewals in a timely manner and communicate timelines with all partners.
Archive essential documents, such as product information, ensuring the quality part of the dossier is archived and updated in line with company procedures.
Share essential information from the dossier post-approval with implicated departments according to relevant procedures.
Keep the regulatory database up to date for projects in the region.
Stay informed on the latest regulatory requirements in the region and inform interested parties, such as commercial, business development, and top management on the regulatory status in the respective area.
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