Medical Affairs Manager

4 weeks ago

Mumbai, India Ipca Laboratories Limited Full time
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.

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