• 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 SOPs
• 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.
Relevant Work Experience
Industry: Any / Others
Role Category: Others
Employment Type: Full time