
Regulatory Affairs Specialist
19 hours ago
Role Summary
We are seeking a skilled Regulatory Affairs Specialist to join our team. The primary goal of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.
This position involves coordinating with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.
About the Role
- Screen and analyze documents received 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 (e.g., DOC, COA) 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 (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
- Ensure timely preparation and submission of documents related to audit findings.
Key Skills Required
- Knowledge of international regulatory requirements and guidelines.
- Expertise in dossier compilation, review, and submission processes.
- Ability to prepare and analyze technical and compliance-related documentation.
- Familiarity with audit documentation and regulatory query management.
- Document management and record-keeping skills.
About You
- Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
- 3-6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
- Strong understanding of global regulatory guidelines and dossier preparation.
- Detail-oriented, with excellent organizational and analytical skills.
- Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
- Good written and verbal communication skills.
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