Job Purpose Submit product documents to regulatory authorities (specifically in SAGA (South Africa / Greater Africa)) region 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 cerficates without impactng 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 cerficates, 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 funconal 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 idenfied for South Africa launch from time to time
Participation and detailed discussion for gap analysis closure meeting
Keeping up to date with registraon 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 respective software
Time to time updation in PRC database, RA table updation,
Education Qualification B.Pharmacy, M. Pharm, or MSc
Relevant Work Experience Minimum 3-4 years experience in regulatory activity in pharma industry preferably worked for same region/authority (South Africa / Greater Africa - SAGA)
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