| Job Location | Dubai, United Arab Emirates |
| Education | Not Mentioned |
| Salary | Not Mentioned |
| Industry | Employment Placement Agencies/Recruiting |
| Functional Area | Not Mentioned |
This is a Contract role under ManpowerGroupROLE SUMMARY: Supporting the regulatory projects and executing timely health authority submissions in the region. Coordinate and liaise with country regulatory managers, global regulatory and BMS partners (primarily of GEM, and RSA and also if required other countries of MEAI Turkey cluster). Provide regulatory support to ensure compliance with the local regulations and uninterrupted access of drugs to patients.AREAS OF RESPONSIBILITY: ? Coordinate and liaise with Country regulatory managers (primarily of GEM and RSA, also if required other countries of MEAI Turkey cluster).? Coordinate and liaise with global regulatory and labelling team.? Coordinate and liaise with BMS partners in South Africa? Coordinate and liaise with Parexel for mature products? Preparation of submission ready dossiers/documents for new drug applications and other related regulatory activities (e.g. response to Health Authority (HA) questions) both in paper and in electronic (e CTD) format.? Preparation of submission ready dossiers/documents for post registration variations and MA license renewals both in paper and in electronic (e CTD) format.? Prepare and manage label updates for submission to the local HA.? Ensure timely submissions to HA and follow up for approvals.? Respond to HA queries and correspondences.? Liaise with local translator to translate HA approved labeling into Arabic. Coordinate with vendors for labeling requirements and Insert artworks for Middle East.? Coordinate with local Medical Advisor to proofread Arabic insert.? Maintain and manage label updates: review labels, maintain labels and update relevant BMS systems/trackers/repositories for compliance with BMS SOP and local regulations.o Ordering of CPPso Request for legalization, notary and apostilleo Sample orderingo Price certificate forms (for renewals)o Proofreadingo Comparison Tables? Track and monitor label update submissions/approvals.? Initiate PPCCRF forms and coordinate with the Production site for any changes and implementations.? Coordinate with Global Labeling team/NACC Labeling Specialist and Global Production team for the composition copies and development of artworks.? Maintain accurately and timely update BMS regulatory systems.o VERITYo GAMEo PRISM/CARAo Regulatory SharePoint/Labelingo Labeling tracker for GEM, Saudi Arabia, RSA? Support specific regulatory projects for the region as per need.? Record product complaints in Trackwise and follow up.? Electronic archiving of regulatory files, product submission files, correspondences and artworks.? Collaborate with various cross functional teams at a local/regional/global level? Attend monthly GRS meeting and track important topics for follow-ups.? Submit eTime on a monthly basis.
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