Regulatory Affairs Officer

12 hours ago

Ahmedabad, India Winston HR Services,Ahmedabad Full time

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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