Otsuka Pharmaceutical India Private Limited is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan, for Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segments. Being a leader in intravenous nutrition products, we are committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition.
Post : Process Incharge / Sr. Process Incharge - Regulatory Affairs (ROW market)
Qualification : B.Pharma, M.Pharma
Experience : 02-05 years
Location : Ahmedabad (Corporate Office)
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 sale 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, 8 Block, Westgate, near YMCA Club, S.G. Highway, Ahmedabad-380015, Gujarat
Email ID : careers@otsukapharma.in
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