Drug Regulatory Affairs

3 days ago


Noida Sector Noida Uttar Pradesh, India Florencia Healthcare (P) Ltd Full time

**Company description**

Florencia Healthcare is a research driven pharmaceutical group engaged in marketing & exporting of Quality, Safe and Genuine healthcare products to all sections of the society. Over the years, we have move forward aggressively, consistently winning new customers worldwide and making our way into challenging new markets and regions.

**Job description**

**Drug Regulatory Affairs - Job description**

**Duties & Responsibilities:

- **
- Prepare CTD, ACTD Dossiers and file regulatory submissions
- Perform assessments of new or revised products
- Manage complaint documentation (including investigation and closure)
- Respond to inquiries from regulatory bodies
- Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines
- To Coordinate with relevant department for arranging documents
- To prepare / compile dossier for allocated products / countries
- To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc
- To coordinate with courier agency for dispatches of dossier /samples
- To make timely entries of submissions / dispatches
- Should be aware about Microsoft office [word / Excel/ PPT] - Good in data management

Contact: 8810226562

**Job Types**: Full-time, Walk-In

Pay: ₹15,000.00 - ₹23,000.00 per month

Work Location: In person



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