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