Job Purpose This role will be responsible for project managing the filings, site audits across Iraq, Yemen and select MENA markets to ensure short/long term strategies for the region are successfully executed. Key Accountabilities Commercial/supply feasibility assessment and DRFs Co-ordinate with commercial team to finalise business case of the product, evaluate margins. Post successful commercial feasibility raise DRFs in the system and ensure timely approval from various stakeholder Identify sources of products which are part of wish list and co-ordinate with portfolio and BD team for inclusion in filing plan Work with Business , Portfolio , capacity team with respect to capacity constraint units and obtain Capacity clearance (wherever required) Raise request with Portfolio for product evaluation and track product evaluation feedback along with RA Project manage the filings for Inhouse products Prepare action charter for each filing, arrange meeting with CFT including QA (unit, CQA, EUQA) , legal ,DSD on MAH decision and other points during filing. Extend support wrt FG code creation , PBOM closure , communicate with medical team for latest pack insert , SPC preparation. Arrange meeting with Partner, Business , RA and minute out key points , circulate minutes of the call with key action items for path forward. Project manage the filings for 3rd party products Ensure Third party dossier checklist (including Business and RA information) is shared with Third party QA, Ensure product is included in agreement with respective FP manufacturer, Ensure P2P FP site approval by CQA Ensure PAF availability. Provide support to RA For arranging documents for Finishes product site registration Arrange documents for finishes product registration : FP licence application including document arrangement (local , export) , artwork finalization , FP site & FP dossier registration document submission. Arrange meeting with CFT (internal stakeholders) wherever reqd. for COPP application and other documentation Artwork finalization with packaging and approval of the same from partner Support Business , RA in localization proposals (if any) , necessary data generation as applicable , Track each project from end to end. Support RA , Business team wrt Import permit application eg document arrangement , close co-ordination with Partner for Import permit receipt. Skills & Knowledge Educational qualifications: Post graduate ( Preferably in pharma) Relevant experience: 2-3 years of pharma project management experience with understanding of basic RA (filing) concepts Must have good communication skills and ability to work with senior stakeholders. Overall 4-5 years of pharmaceutical business experience
