Drug Regulatory Affairs
5 months ago
**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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