Conduct thorough reviews of all data and documents related to product registrations, ensuring compliance with the requirements of various health authorities.
Dossier Compilation:
Compile and prepare comprehensive registration dossiers for submission to global health authorities, including those in the US, Canada, Europe, Australia, and China.
Regulatory Responses:
Prepare detailed responses to deficiency letters received from various regulatory agencies, addressing any issues or concerns raised.
Life-Cycle Management:
Maintain and manage the life cycle of drug product registration dossiers, including handling post-approval changes to ensure ongoing compliance.
Cross-Functional Regulatory Support:
Provide regulatory support and guidance to cross-functional departments, helping to ensure that all aspects of the product lifecycle are compliant with regulatory standards.
Scientific Advice Preparation:
Prepare and submit scientific advice documents to various health authorities, supporting product registration and approval processes.
eCTD Management:
Manage the compilation, verification, and submission of dossiers using the Electronic Common Technical Document (eCTD) format through electronic gateways.
Preferred Experience:
Experience in handling regulatory affairs for non-oral drug products is highly preferable, adding a specialized dimension to the role.
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