
Regulatory Affairs Specialist
1 day ago
We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.
Key Responsibilities:- Document Preparation and Review: Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
- Regulatory Query Management: Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
- Audit Support: Ensure timely preparation and submission of documents related to audit findings.
- Education: Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
- Experience: 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
- Skills: Strong understanding of global regulatory guidelines, dossier preparation, MS Office (Word, Excel, PowerPoint), and document management systems.
At our organization, we promote diversity and equality. We encourage applications from talented individuals who share our values and are committed to excellence.
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