Otsuka Pharma Walk In Interview For Regulatory Affairs
Position Details
Designation : Process Incharge / Sr. Process Incharge - Regulatory Affairs (ROW market)
Qualification: B.Pharma, M.Pharma
Experience : 02-05 years
Location : Ahmedabad (Corporate Office)
Email ID : careers@otsukapharma.in
Roles and Responsibilities:
- Dossier preparation/review as per country-specific guideline/CTD guideline
-Timely query response submission to Distributor/ MOH
- Review of documents for their correctness and compliance with respective regulatory guidelines (as per country requirement)
- Preparation, review, and release of artwork and sales orders as per country approval
- Variation documents preparation and filing as per country requirements
- Timely dispatch of tender documents to country/ parties as per deadline
Desired Profile:
-Regulatory Affairs experience is mandatory.
-Should be able to review and interpret the country-specific requirements
-Should be able to review various plant documents for dossier preparation like Process Validation, Stability Study,
-PDR, Method Validation, SOP, Drug Master file, BMR, APR, etc. -Should be able to communicate with relevant functions for procurement of required regulatory documents
-Should be able to communicate with relevant counterparts in the countries -Immediate joiners preferred
Note:
1. Simply walk into the interview venue at the specified date and time provided if you have prior experience in Regulatory Affairs
2. Bring a copy of your updated resume and any relevant documents
Interview Details:
Date: September 23, 2023
Time: 09:00 AM - 02:00 PM
Venue: Otsuka Pharmaceutical India Pvt. Ltd. 21 Floor, B Block, Westgate, near YMCA Club, S.G. Highway, Ahmedabad-380015, Gujarat
Otsuka Pharma Walk In Interview For Regulatory Affairs |
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