Pharmacy Jobs – Team Member Regional | Cipla Careers

Team Member – Regional RA

 

Job Purpose
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

Accountabilities
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.

Education Qualification
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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