Regulatory Affairs Executive - Noida, India - Florencia Healthcare

Florencia Healthcare

Verified Company

Noida, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

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, ₹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: