Key Responsibilities:
- Data and Document Review:
- 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.
