Manage end-to-end regulatory submissions across the Middle East (UAE KSA GCC) including application preparation tracking and authority coordination (e.g. MoHAP SFDA).
Prepare and review regulatory dossiers and technical documentation aligned with EU MDR and regional authority requirements ensuring completeness and submission readiness.
Conduct product classification labeling/claims compliance checks and gap assessments for market entry across UAE and GCC markets.
Liaise with clients internal teams and regulatory authorities to support approvals renewals and query/deficiency responses.
Monitor regional regulatory updates and maintain submission trackers documentation and compliance records.
Qualifications :
Bachelors degree in pharmacy Biomedical Engineering Life Sciences Chemistry or related field.
25 years of experience in regulatory affairs product registration or conformity assessment fo...
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