Team Member – Regional RA
Submit product documents to regulatory authorities in accordance with country specific regulatoryrequirements to ensure approvals and market launch in stipulated time and handle post-approval changes,maintenance, and updation of documents during the products life-cycle
Compilation & finalisation of RA strategy documents for South Africa Namibia & Botswana.
Coordination with india based CDT team & 3rd Parties to recieve the dossier sections for SA, Namibia & Botswana
Compile the dossier sections for 3rd party as applicable
Follow up & arrangemnet of FP sample, relevant FP COA, Executed BMR, BPR & other data from manufacturing site to get declaration letters & GMP certificates without impacting the dossier submission timeline.
Coordination with dfferent stakeholders like API RA &/ Procurement team to get confirmation on DMF.
Coordination with different regional regulatory colleagues to get registration certificates, PI,PIL.
Coordination with Clinical team to arrange & review of BTIF as per guideline and alignment of Module 5.
review of deficiency letter and arrange for CFT meetings with relevant stakeholder for discussion.
Actively participate in each discussion with cross functional team and provide feedback upfront for gap analysis compilation by Mfg site presonnel.
timely review of GAP analysis & identification of variation based on EMEA Variation guidelines
Participation and detailed disscussion for gap analysis closure meeting
Keeping up to date with registration guideline( new guideline & amendment guideline) and company parctice & SOP’s
Review & approval of Artworks & PM specification
Mantainence of relevant databases.
B.Pharmacy, M. Pharm, Bsc or MSc
Relevant Work Experience
5-8 years experience in regulatory activity in pharma industry preferably worked for same region/authority
Job Location: Vikhroli
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