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Thursday, March 11, 2010

Officer – Regulatory & QA



Desired Candidate Profile
Designation: Officer – Regulatory & QA, India

Location: Mumbai

Knowledge and experience:

Bachelors in Pharmacy

1-3 years experience with product registrations.

Good knowledge of English language, both oral and written.

Knowledge of French and/or Spanish is an advantage.

Ability to work in a team.


Job Description
Job Objectives:
To get marketing authorizations (registrations) with our client (or its designated agent) as marketing authorization holder for our client products (Our client packaging and labelling) in those countries where there is a registration requirement and our client aims to sells its products. The registrations are required to be allowed to sell the products.

Reporting:

The Officer – Regulatory & QA reports to the Unit Manager Product Registrations in Mumbai.

Responsibilities

1) Effective planning and execution.
Tasks

- Meeting the targets allocated to him/her by means of the registration planning.

- Follow-up and completion of queries raised by DRA allocated to him/her within timelines given.

- Maintenance of flawless documentation.

- Align requests for samples with planning of submission of registration dossiers.


2) Registration Dossiers.
Tasks

- Review of basic registration dossiers submitted by manufacturers to our client. The Junior officer ensures that the product dossier as supplied by the manufacturer is revised and completed on the basis of the dossier template, our client product specifications and the respective country guidelines by means of a checklist.

- Submission of registration dossiers to DRA’s in compliance with the country guidelines and our client's product specifications.

- Review of registration dossiers prepared by another registration officer prior to submission to ensure that the dossier does not contain errors or shortcomings.

- After submission of the dossiers to the DRA a soft copy (PDF format) of the same to be maintained in order to have a backup of the dossier submitted.


3) Approval of Registration Dossiers by DRA’s.
Tasks

- Preparation of replies on queries sent by DRA’s in coordination with the unit manager. Record the same in the Topdesk system.

- Recognition of patterns in queries sent by DRA’s and complies with the revised work instructions before submitting the dossiers to the DRA.

4) Variations and Renewals
Tasks

- Preparation and submission of renewal requests

- Preparation and submission of variation requests


5) Communication with suppliers
Tasks

- If required communication with suppliers regarding requested items, developments in dossier requirements and registration overviews.


The activities will be performed in the Product Registrations Department in Mumbai and reported to the Unit Manager and/or head of the department.
Within the department there will be assistance for administrative and general support.


Keywords: Product registrations, Regulatory Affairs, Regulatory Officer, Regulatory Officer & QA, Registration Dossiers, Pharma, Pharmacy.
Summary
Experience:1 - 4 Years
Location:Mumbai
Education:UG - B.Pharma - PharmacyPG - Post Graduation Not Required
Industry Type:Pharma/ Biotech/Clinical Research
Role:Regulatory Affairs Mgr
Functional Area:Healthcare, Medical, R&D

Company Profile
Our client was established in 1972 by a small group of pharmacists. Their goal was to make healthcare accessible and affordable for those people in the world who are most in need of medicines and medical supplies. In order to make sure that the delivered products were of high quality they set-up an extensive quality assurance system.

Our client’s corporate headquarters are located in Amsterdam, the Netherlands.

In 2006, we established an office in Mumbai, India, with a dedicated Quality Affairs department. Our Indian staffs focuses specifically on matters such as quality assurance, procurement from Indian sources, drug registration, laboratory testing and quality control monitoring.

Contact Details
Company Name: Client of Mploy
Website: http://www.mploy.co.in
Executive Name:Vicky Gulekar

Email Address: vicky@mploy.co.in
Telephone: 91-22-65241509
Reference ID:Officer – Regulatory & QA - Mumbai

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