Medical affairs manager

Designation : Asst Manager / Manager – Medicoregulatory Affairs

Department : Medicoregulatory Affairs

Job location : Kandivali-West, Mumbai

Responsibilities

I To independently review following applications online through Sugam Portal to CDSCO :

Import license of reference product for BE studies

BE study NOC for export purpose

Manufacture of new drugs to be introduced for the first time in India or to undertake clinical trial

Manufacture of fixed dose combination

Protocol amendment of clinical trial

Clinical trial site addition / deletion / closure or change in principal investigator

NOC for Form 29 for clinical trial samples

Manufacture of new bulk drugs (API)

Marketing of an already approved drug with new indication

Marketing of an already approved drug as a new dosage form or new route of administration

Marketing of an already approved drug as modified release dosage form.

Marketing of an already approved drug with additional strength

Export of biological sample

NOC for Form 29 for development purpose

Permission to manufacture and export API.

II. To review updated pack inserts

III. To review therapeutic rationale

IV. To review patient information leaflet

V. To initiate PIF

VI. To handle regulatory queries from various departments

VII. To screen updation of Indian regulatory guidelines on weekly basis

VIII. To prepare SOPs for Medicoregulatory Section

Qualification - M Pharmacology

Experience - 8 - 10 years.