
Senior Regulatory Affairs Specialist
7 days ago
As a regulatory affairs expert, you will play a pivotal role in ensuring our products meet international compliance standards and country-specific requirements.
- Prepare and maintain high-quality regulatory documents to support product registrations and dossier submissions.
To excel in this position, you should possess:
- A graduate or postgraduate degree in a relevant field such as Pharmacy, Life Sciences, Biotechnology, or related disciplines.
- 3–6 years of experience in regulatory affairs, preferably within the pharmaceuticals, biotechnology, or healthcare sectors.
- A strong understanding of global regulatory guidelines and dossier preparation best practices.
- Excellent organizational, analytical, and communication skills to effectively collaborate with internal teams and external stakeholders.
- Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
The ideal candidate will possess:
- In-depth knowledge of international regulatory requirements and guidelines.
- Expertise in dossier compilation, review, and submission processes.
- Ability to prepare and analyze technical documentation with precision and accuracy.
- Familiarity with audit documentation and regulatory query management.
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