Interested & eligible candidates need to apply online via given link. The last date to apply Cipla Team Member Recruitment is 25/11/2020. You will get brief information like educational qualification, selection process, eligibility criteria, and important dates in the below article. So read this article till the end to get all the information regarding this recruitment.
| Job opportunities in Cipla as Team Member | |
|---|---|
| Organization Name | Cipla |
| Post Name | Team Member - Regional RA |
| Job id | 42966 |
| Educational Qualification | B.Pharmacy, M. Pharm or MSc |
| How To Apply | Online /LinkedIn |
| Official Website | cipla.com |
Required Experience:
- Minimum 3-4 years of experience in regulatory activity in pharma industry preferably worked for same region/authority i.e. SAGA (South Africa / Greater Africa)
Job Description
Job Purpose
Submit product documents to regulatory authorities (specifically for the SAGA - South Africa / Greater Africa) countries in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle
Accountabilities
• Compilation and finalization of RA strategy documents for South Africa, Namibia and Botswana.
• Coordination with India based CDT team and 3rd parties to receive the dossier sections for SA, Namibia and Botswana submission Compile the dossier sections for 3rd party products (as applicable).
• Follow-ups and arrangement of FP samples, relevant FPCoA, Executed BMR, BPR and other data from Manufacturing site to get declaration letters and GMP certificates without impacting dossier submission timeline.
• Coordination with different stakeholders like API – RA (if the API supplier is In-House) and Procurement team to get confirmation on DMF.
• Coordination with different regional Regulatory colleagues to get registration certificates, PI & PIL and also to cross verify about Mfg. formula of their respective countries
• Coordination with clinical team to review and complete BTIF as per guideline and alignment with Module 5.
• Review of deficiency letter and then arrange for CFT with the right stakeholders for discussion.
• Actively participate in each discussion with the cross functional team and provide feedback upfront for gap analysis compilation by Mfg. site personnel.
• Timely review of Unit gap analysis & provide feedback on any amendments needed; for products identified for South Africa launch from time to time
• Participation and detailed discussion for gap analysis closure meeting
• Keeping up to date with registration guideline (new guideline & amendment guideline) and company practice and SOP’s
• Timely review and provide feedback on market complaints & NCE from different authorities on API Suppliers and excipient suppliers
• Review and Clearance of artwork, CMCL, SPS from different respective software by comparing
• Time to time updation in PRC database, RA table updation, PSMF updation.
Selection Process:
- Based on Written / Personal Interview
Pay Scale:
- NA
Job Location:
- Vikhroli, Mumbai
| Important Date | |
|---|---|
| Last Date | 25/11/2020 |
| Important Links | |
| Apply Now | |
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