
Regulatory Affairs Professional
3 days ago
The Regulatory Affairs Specialist plays a vital role in ensuring compliance with international guidelines and country-specific regulations.
- Preparation, review, and maintenance of regulatory documents to guarantee adherence to international guidelines and country-specific requirements.
- Coordination with internal teams and external stakeholders to facilitate product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.
- Screening and analysis of documents received for product registration requests in accordance with country-specific guidelines.
- Prioritization of dossiers to meet defined timelines and ensure timely submission to regulatory authorities.
- Drafting and coordination of responses to regulatory queries with supporting documentation and justifications.
- Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
- 3-6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
- Strong understanding of global regulatory guidelines and dossier preparation.
- Attention to detail, excellent organizational, and analytical skills.
- Familiarity with international regulatory requirements and guidelines.
- Expertise in dossier compilation, review, and submission processes.
- Able to prepare and analyze technical and compliance-related documentation.
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