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Milan Laboratories
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Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive

Milan Laboratories

8 - 12 years

5 - 7 Lacs

Panvel

Posted:2 months ago| Platform:

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Regulatory Affairs

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Job Type

Full Time

Job Description

Greetings from Milan Laboratories (India) Pvt. Ltd. Currently we are hiring for Senior Executive - RA at the Panvel location. Below are the requirements: Qualification: B.Pharm/M.Pharm/Diploma in RA Experience: 8 to 11 years in Pharmaceutical industry - Formulations Job location: Kamothe, Panvel No of vacancy: 1 Role & responsibilities 1. Preparation & Compilation of registration dossiers for non-regulated, semi regulated and regulated markets. 2. Collection of dossier documents from various departments like QC, QA, Stores, Production, FD, Stability and maintaining in a master document with systematic manner. 3. Submitting and reviewing the technical requirements for Tender Filing 4. Review of specifications as per monographs. (USP/Ph.Eur). 5. Review of process qualification and product development records. 6. Review of stability data. 7. Review of innovator comparative dissolution data. 8. Review of all documents related to Formulation Development. 9. Art work review and approval 10. Review, submission of quality dossiers as per the current guideline (country specific) requirements and attending the MOH query. 11. Document follow up for FDA/Regulatory Queries 12. Raising applications for product license, COPP, FSC as per requirement. 13. Communication with customer for the country specific registration requirements. Interested candidates can share their resume at: Email ID: talentpool@milanlabs.com WhatsApp: 8828829932 Best Regards Anagha Dalvi Senior Officer - HR Milan Laboratories (India) Pvt. Ltd.

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Senior Regulatory Affairs Executive