Regulatory Affairs Associate
Current- Collaborated with cross-functional teams to ensure timely submission of regulatory documents for new product registrations, including new drug and new generic drug with eCTD. - Reviewed and submitted bioequivalence and biowaiver reports, ensuring compliance with regulatory standards.- Applied variations to maintain product information in compliance with local regulations and keep registration licenses up to date throughout the product lifecycle.- Managed GMP clearance application submissions and renewals, ensuring continuous validity of clearance letters.- Oversaw the renewal and amendment processes for company import permits and wholesale licenses.- Submitted BE import permit applications to facilitate the import of product samples for local bioequivalence studies.- Conducted thorough research on current regulations and guidelines to provide internal stakeholders with guidance on compliance requirements for pharmaceutical products.- Submitted CIOMS forms to regulatory authorities, ensuring adherence to company principles and local requirements.- Supported the marketing team as needed.- Developed and maintained positive relationships with local regulatory authorities.
