
Regulatory Affairs Specialist
17 hours ago
Regulatory Affairs Professional
About the Role- This key position is responsible for managing and preparing regulatory documents to ensure compliance with international standards.
- The successful candidate will have a strong understanding of global regulatory guidelines and dossier preparation, allowing them to analyze documents received for product registration requests.
Main Responsibilities:
- Preparation and review of product dossiers in compliance with customer and regulatory requirements.
- Timely submission of dossiers to regulatory authorities while prioritizing tasks to meet deadlines.
- Drafting and coordinating responses to regulatory queries with supporting documentation.
- Collation of batch-related documents for registration samples.
- Management of legalization or apostillation of registration documents, including coordination with agencies and tracking timelines.
Key Requirements:
- Bachelor's or Master's degree in a relevant field such as Pharmacy, Life Sciences, Biotechnology, or related discipline.
- Minimum 3-6 years of experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
- Excellent attention to detail and accuracy in work.
- Ability to work under pressure and meet strict deadlines.
This role offers opportunities for professional growth and development within a dynamic team that values collaboration and teamwork. A competitive compensation package is also provided.
Working EnvironmentThis is an individual contributor role reporting directly to the Assistant Manager - RA. The working environment is supportive and encourages open communication and knowledge sharing.
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