Regulatory Affairs Executive Post @ Intas – Pharma Jobs
Regulatory Affairs Executive Post. Intas Pharmaceutical Limited invites undergraduates Pharma candidates for officer post vacancy. Candidates with experience in Pharma filed may apply for this job post via online mode. Check out all the details on Rasayanika.com
Job Title: Executive – Regulatory Affairs
Location: Ahmedabad
Eligibility: B Pharma
Experience: 2 – 7 Years
Salary: INR 3,50,000 – 6,00,000 PA.
Job Description:
JOB RESPONSIBILITIES:
- Perform following regulatory related work
- Submission of study documents to Indian Regulatory authorities (DCGI) for NOC, T-license, CBN, CT projects, Notifications, Amendment etc.
- Reporting of Serious Adverse Events (SAE) to regulatory authorities
- Responding to queries from DCGI on dossier application
- Tracking of the projects approval, acknowledgement copies of SAE and Notifications from DCGI
- Review of the documents provided by the sponsor
2. Support in performing following EC related work
- Coordination with protocol writing (CTM-Medical Services) and operations (CPMA) teams and Ethics Committee (EC) which includes,
- Coordination with member secretary/coordinator of EC
- Coordination with investigators
- Coordination with protocol writing, operations, QA, admin and finance teams\
- EC Submission which includes,
- Verification of the dossier for its completeness
- Uploading soft-copies of applicable documents of the dossier on the web-share of EC
- Arrangement and coordination with admin, security and EC for dispatch of the dossier to EC
- Compilation and verification of documents received from EC
- Handing-over the documents to the protocol writer / project coordinator
- Verification of finance / payment related documents (e.g. Invoice)
- Arrangement and management of the facility visits of EC members
- Maintenance of EC related common documents (e.g. EC composition, EC SOPs, etc.)
- Archival of EC related documents
- Verification of various documents including compensation calculation for the study and compensation for discontinued subjects
- Support to BD and protocol writing (CTM-Medical Services) teams and project coordinators (CPMA) in various day-to-day EC related activities
3. Any other responsibilities as assigned by the Management / HOD.
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