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Regulatory Affairs Executive

4 weeks ago

Noida, India Florencia Healthcare Full time

**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**: ₹16,000.00 - ₹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**:

- FDA regulations: 1 year (required)
- actd: 1 year (required)
- total work: 1 year (required)