Milan Laboratories – Hiring for Regulatory Affairs Department – Apply Now
Greetings from Milan Laboratories (India) Pvt. Ltd.!!
We are looking for Regulatory Affairs Officer/Sr. Officer at our Panvel factory.
1. Preparation & Compilation of registration dossiers for row, 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.
14. Arrangement of samples for registration purpose.
Interested candidates can share their resume at firstname.lastname@example.org