
Chief Regulatory Compliance Officer
2 weeks ago
We are seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for ensuring that all regulatory submissions are complete and compliant with international requirements.
Main Responsibilities:- Prepare and submit new dossiers in electronic Common Technical Document (eCTD) format for regulatory approval worldwide.
- Analyze gaps in dossier completeness and coordinate with manufacturers to obtain necessary information and documentation.
- Compile and submit dossier packages across multiple countries, managing timelines and deadlines effectively.
- Manage the receipt and response of query letters from country teams, coordinating with manufacturers as needed.
- Evaluate and finalize query responses to ensure they meet regulatory standards.
- Distribute finalized query responses to respective countries, maintaining compliance and adherence to deadlines.
- Oversight of product lifecycle post-approval, including variations and renewals.
- Collaboration with manufacturers for variation/renewal packages, reviewing them against country guidelines.
- Compilation and distribution of final variation packages to respective countries, ensuring harmonization across all territories.
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Regulatory Compliance Specialist
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