Intas Pharmaceuticals Announcement For Job Seekers

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.
  • Review International dossier related documents.

Click here for notification and Apply

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