Drug Regulatory Affairs

5 months ago


Noida, India Docthub Health Tech Private Limited Full time

**Description**

Drug Regulatory Affairs - Job description
- 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 medicines, food supplement,
- 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.

Qualifications:
- A bachelor’s degree in B. Pharma.
- Experienced with (2 years to 6 yrs) both can apply.
- Excellent communication skills.
- Should be aware about Microsoft office [word / Excel/ PPT] - Good in data management.

**Category**

Regulatory Affairs / Pharmacovigilance

**Preferred Education**

MPharm, Regulatory Affairs, BPharm (Bachelor Of Pharmacy)

**Key Skills**

Regulatory Knowledge, Documentation Management, Regulatory Strategy, Communication Skills

**Salary**: ₹25,000.00 - ₹50,000.00 per month

**Experience**:

- total work: 1 year (preferred)

Work Location: In person



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