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Winston HR Services looking for Executive in Regulatory Affairs

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Winston HR Services is a HRD division launched by HR professional providing manpower recruitment & staffing services to Pharma, Chemical, Dyes, IT, Plastic, Engineering, Textile, Retail, Telecom, electrical & many more industries.

Post: Regulatory Affairs - 03 Posts


Job Description
-Preparation of New dossiers as per the CTD Guidelines. 
- Preparation of the re-registration documents 
- Replying to queries for various countries. 
- Checking dossiers, artworks, and technical documents. 
- Review of all the documents, which is part of dossier submissions like Batch Manufacturing & Packing Records, Process Validation Protocols, COAs, Stability Data etc. required to be submitted to the health Agencies in support of the new product submission/ variations. 
- Practice to prepare Process validation data, Process Development data, Packaging Specification, PIL etc.


Candidate Profile :
 - Provide regulatory supports/inputs to various departments as and when required. 
- Maintenance of the office copies of the sent dossier/documents. 
- Searching & studying literatures of competitors / innovators for dossier submission, pharmacological data, toxicological data, adverse drugs reactions and also published literatures on scientific websites. 
- Coordinate with F&D, QC, QA, Production etc. to collect the complete set of documents. 
- Dispatch of product samples and technical documents to clients.
- Direct Coordination with International Clients for Registration objective. 
- Prepared Dossiers for the countries (ROW Market) like Afghanistan, Kazakhstan, Uzbekistan, Ukraine, Cambodia, Myanmar, Nigeria, Ghana, Srilanka, Vietnam.

Please provide the following details:
1. Total Yrs of Exp:
2. Current Organization:
3. Current CTC:
4. Expected CTC:
5 Willing to relocate to Ahmedabad? : --------(Y/N)
6. Contact Number:
7. Notice Peroid:
8. Suitable Date and Time for Interview:

Additional Information
Qualification: B.Pharm, M.Pharm
Location:  Ahmedabad

Salary: 1.0 to 3.0 LPA
Industry Type:
Pharma/ Biotech/Clinical Research

Functional Area: Regulatory Affairs
End Date: 16th August, 2016

Send your CV to:

Posted by,
Winston HR Services

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