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Regulatory Affairs Executive
3 weeks ago
**JOB DISCRIPTION ( Drug regulatory affairs )**
**1. Drug Regulatory Affairs - Job description**
Ø Prepare CTD, ACTD Dossiers and file regulatory submissions
Ø Perform assessments of new or revised products
Ø Manage complaint documentation (including investigation and
Ø closure)
Ø Respond to inquiries from regulatory bodies
Ø Should be technically well versed with requirements for medicines with fare knowledge about medicines, food supplement,
Ø To Coordinate with relevant department for arranging documents
Ø To prepare / compile dossier for allocated products / countries
Ø To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc
Ø To coordinate with courier agency for dispatches of dossier /samples
Ø To make timely entries of submissions / dispatches
**Qualifications:
- **
Ø A bachelor’s degree in B. Pharma
Ø Experienced with (1 year to 5 yrs) both can apply.
Ø Excellent communication skills
Ø Should be aware about Microsoft office [word / Excel/ PPT] - Good in data management
**Salary**: ₹14,000.00 - ₹25,000.00 per month
Schedule:
- Day shift
Ability to commute/relocate:
- Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
**Speak with the employer**
+91 9968996869
