Regulatory Affairs Officer
1 day ago
Greetings of the day.
We have urgent requirement for Regulatory Affairs (RA) Officer for Pharma (Tablet, Capsule) company at Moraiya, Ahmedabad.
Pls find detail.
**1 Post** : Regulatory Affairs (RA) Officer
**2. Exp**: 1.0 Yr to 3.0 Yrs
**3. Location**: Moraiya, Ahmedabad
**4. Transport**: Available
**5. Qualification **:B.PHARM./M.PHARM./B.SC./M.SC.
**JD- As attached format.**
Ø Preparation of new dossiers as per the CTD Guidelines.
Ø Preparation of the re-registration documents.
Ø Replying to queries for various countries.
Ø Checking dossiers, artworks, and technical documents.
Ø 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.
Ø Practice to prepare Process validation data, Process Development data, Packaging Specification, PIL etc.
Ø Provide regulatory supports/inputs to various departments as and when required.
Ø Maintenance of the office copies of the sent dossier/documents.
Ø Searching & studying literatures of competitors / innovators for dossier submission, pharmacological data, toxicological data, adverse drugs reactions and also published literatures on scientific websites.
Ø Coordinate with F&D, QC, QA, Production etc. to collect the complete set of documents.
Ø Dispatch of product samples and technical documents to clients. - Direct Coordination with International Clients for Registration objective.
Ø Prepared Dossiers for the countries Latin America, African Countries.
**About Our Client**:
**Brief Overview**:
Our client is manufacturer of Pharmaceuticals dosage forms tablet, capsule, Oral liquids & External preparations.
You can pass these openings to your friends & colleagues if they match with the criteria's.
While sending the mail, please don't change the Subject in the mail or else your mail will be sent to spam folder.
**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 Period:
8. Suitable Date and Time for Interview:
**PLS TREAT THIS AS MOST URGENT**
Further details call me on same number.
-------------------------
- Winston HR Services,
Ahmedabad, INDIA.
Thanks & Regards,
Vaishali
Tel:
+91-7383005000
, +079 48900309
Company Profile
Winston HR Services
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.
**Salary**: ₹15,000.00 - ₹30,000.00 per month
Schedule:
- Morning shift
Ability to commute/relocate:
- Sanand, Ahmedabad - 382213, Gujarat: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
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