Milan Laboratories – Hiring for Regulatory Affairs Department – Apply Now

Milan Laboratories (India) Pvt. Ltd. is one of the leading Pharmaceutical Manufacturer and Exporter from India. An ISO 9001:2008 and WHO-cGMP certified company, is a Govt. Recognized Star Export House and a winner of various awards for Quality Excellence and Outstanding Export Performance. There is a manufacturing facility for Tablets, Capsules, Liquid Orals, Dry Syrups, Ointments and a dedicated facility for Beta Lactam Products (Penicillin Group). Our Plants are approved by drug regulatory authorities of various countries out of which, a leading few are South Africa – MCC and UK – MHRA. There is a in-house Research & Development department that develops new formulations and also modifies and improves the existing ones. A dedicated team for Regulatory Affairs prepares in-house eCTD Dossiers for filing in the Regulated markets.

Dear Candidate,

Greetings from Milan Laboratories (India) Pvt. Ltd.!!

We are looking for Regulatory Affairs Officer/Sr. Officer at our Panvel factory

Vacancies: 2

Job responsibilities:

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 talentpool@milanlabs.com