
Biotech Regulatory Compliance Specialist
13 hours ago
We are seeking a highly skilled and organized Regulatory Affairs Executive to join our organization. The ideal candidate will have a strong understanding of international regulatory requirements and guidelines.
This role involves preparing, reviewing, and maintaining regulatory documents to ensure compliance with country-specific regulations. The successful candidate will be responsible for screening and analyzing documents received for product registration requests, as well as preparing and reviewing product dossiers in compliance with customer and regulatory requirements.
- The Regulatory Affairs Executive will prioritize dossiers to meet defined timelines and ensure timely submission to regulatory authorities.
- They will also draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
- In addition, the Regulatory Affairs Executive will manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
- Expertise in dossier compilation, review, and submission processes.
- Knowledge of international regulatory requirements and guidelines.
- Ability to prepare and analyze technical and compliance-related documentation.
We are a Biotech organization committed to promoting diversity and ensuring no discrimination on any ground. We offer an individual contributor role with opportunities for growth and development.
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