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Life Sciences Regulatory Affairs Vacancies at Florencia Healthcare
Drug Regulatory Affairs at Florencia Healthcare
Company – Florencia Healthcare
Budget – up to 3lpa
Qualification – BSc/MSc Life Science, Biotechnology, Microbiology, BPharm/MPharm
Experience – 1 yr
Interview mode – F2F
Location – Noida
Key Responsibilities
- Prepare CTD (Common Technical Document) / ACTD Dossier(s) and file regulatory submissions for medicines (and where applicable, food supplements).
- Assess new product registrations / revisions of existing products as per regulatory requirements.
- Manage complaint documentation including investigation and closure.
- Respond to inquiries from regulatory authorities / bodies in a timely manner.
- Coordinate with internal departments (e.g. R&D, Quality, Legal) to gather documentation and required inputs.
- Prepare / compile dossiers for products / countries allocated.
- Liaise with Accounts department for Local FDA (or relevant authority) fees, legalization, payments etc.
- Arrange dispatch of dossiers / samples via courier / logistics agencies.
- Maintain timely entries / tracking of all submissions and dispatches.
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