Job Description
- 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...