Urgent vacancies for Executive Regulatory Affairs

By: Pharma Jobs | Views: 2815 | Date: 07-May-2014

We have got vacancies with one of the reputed pharmaceutical company at Mumbai for "Executive Regulatory Affairs".Attractive salary package would be offered.

Urgent vacancies for Executive Regulatory Affairs at Mumbai



We have got vacancies with one of the reputed pharmaceutical company at Mumbai for "Executive Regulatory Affairs".
Attractive salary package would be offered.



JOB DESCRIPTION :
===============
Title : Executive Regulatory Affairs

Locations : Mumbai

Qualification : Bsc / B Pharma

Experience : minimum 2 years

Job Description:

* Co-ordination with various departments and collect inputs required for Regulatory submission.

* Responsible for Preparation, Customization of Drug Master Files (DMFs) in CTD Format for Regulated Markets like US, Europe, Australia, Canada.

* Preparation of DMFs in CTD format as per country requirements for Non-Regulated Markets

* Preparation of Annual Updates and Amendments
* Preparation of CTD (open & closed parts) and TP (technical packages) for US, Europe and other non- regulatory agencies, as per requirements from external customers
* Preparation of action plans & drafting the deficiency response to Deficiencies received from Various Regulatory Authorities.

The candidate should have
* Good Exposure to e -CTD software
* Awareness of latest regulatory guidelines of various countries

Urgently contact Mr.Prasad OR send ur updated cv.


Please provide following details
=========================
Your Present Location :
Total year of experience :
Notice period :


Thanks with regards,

Mr.Prasad.
SHARP COMPANY PVT.LTD.
Andheri(E).Mumbai- 400069
M- 09892067462
Email : shrpconsultancy@gmail.com

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