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.