Regulatory Affairs Specialist
17 hours ago
Job Overview
\We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role involves preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.
\The successful candidate will have a strong understanding of global regulatory guidelines and dossier preparation, as well as excellent organizational and analytical skills.
\Key Responsibilities
\- 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 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.
Requirements
\- 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.
Benefits
\- This is an individual contributor role, reporting to the Assistant Manager - RA.
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