
Regulatory Affairs Specialist
7 days ago
The main objective of this position is to ensure compliance with international guidelines and country-specific requirements.
This role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.
Key Responsibilities- Screen and analyze documents for product registration requests as per country-specific guidelines.
- Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
- Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
- Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
- Arrange supportive batch-related documents for registration samples.
- Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
- Support the Compliance team by providing updated documents required for technical file preparation.
- Periodically review and update Technical Master Files to ensure consistency across product categories.
- Coordinate with cross-functional teams to fulfill regulatory requirements and address audit queries.
- Ensure timely preparation and submission of documents related to audit findings.
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