Job Description

• 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

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Employment Type: Full time

Keyskills