Regulatory Affairs Executive

Milan Laboratories (India) Pvt. Ltd.

Senior Executive - RA

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. Artwork 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. Required ECTD experince

Interested candidates can share their resume at:

·      Email ID: talentpool@milanlabs.com

·      WhatsApp: Ms. Ranna Bhatt 8828829932