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
Experience: 1-4
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: pharmajobs@winstonhrservices.com
Posted by,
Vaishali
Winston HR Services
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