Regulatory Affairs Executive
1 month 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
Pay: ₹20,000.00 - ₹40,000.00 per month
Schedule:
- Day shift
Ability to commute/relocate:
- Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)
Application Question(s):
- can you make dossier ?
**Experience**:
- CTD, ACTD: 2 years (required)
- drug regulatory: 2 years (required)
- total work: 2 years (required)
-
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