Intas Pharmaceuticals Ltd is Hiring for Regulatory Affairs Manager and has issued notification to accept Applications.Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon..Application form link provided at the end of post.
Vacancy summary details :
Company Name: Intas Pharmaceuticals Ltd
Location : Ahmedabad
Post Name: Regulatory Affairs Manager
Qualification: B.Pharma in Pharmacy , M.Pharma in Pharmacy
Experience: 3 years
No of Vacancies: 01
Details of Salary: NA
Closing date for online Application : Apply as soon as possible
Date of examination: NA
Time and Venue :NA
Mode of application : online
Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
Job Description/Skills Required:
Pharmacovigilance of small molecule products.
Preparation and submission of PSUR & RMP to DCGI office in stipulated time.
Maintaining Calendar of PSUR & keeping track of upcoming PSURs.
Preparation and submission of replies related to PSUR queries to DCGI Office.
Apprise the regulatory team on regulatory updates (New Guidelines/Gazettes/SEC MoMs/Notices/New approvals/CT NOC etc) laid down by CDSCO from implication point of view.
Providing regulatory status (e.g. worldwide approval status, CTRI status, available strengths and dosage forms, new indications, combination categorization etc.) and literature related to new/existing products as per the requirement.
Support in dossier preparation and submission for various types of DCG(I) applications for:
Manufacturing and Marketing applications for API & finished formulation.
Clinical Trial NOC.
Bioequivalence study NOC.
Query response in stipulated timelines.
Assisting in preparation for SEC presentation i.e., executive summary, presentation slides, literature set to support presentation.