Regulatory Affairs Officer – Pharmalink & Medicina Group – Oman
- To Review and finalize the Quality Regulatory Agreements with various principals across the globe.
- To comply with Pharmacovigilance regulations of various regulatory bodies and our principals across the globe & to be the primary point of contact for all PV Audits doing by our Principal company
- ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy.
- keep up to date with national and international legislation, guidelines and customer practices
- develop and write clear arguments and explanations for new product licenses and license renewals
prepare submissions of license variations and renewals to strict deadlines
monitor and set timelines for license variations and renewal approvals