Job Description
Responsibilities
- Manage and perform new product registration related activities according to the MOH procedure.
- Maintain the product registration renewal schedule and renew the registration according to the MOH procedure.
- Manage and perform all activities of product variation according to the MOH procedure.
- Prepare the pricing of new Pharma Products.
- Provide the regulatory information to the senior management and ensure the compliance accordingly.
- Responsible to collecting, monitoring, assessing and evaluating the information from healthcare providers and patients on the adverse effects of medications with a view to identifying new hazard and preventing harm to patient (pharmacovigilance).
- Update licensing and collect information on registration instructions and regulations.
- Coordinate and follow up with various departments and MOH related to regulatory affairs till it get resolved.
- Act as a POC (Point of Contact) for the communication between the MOH & Principals and vice versa.
Qualifications & Skills
- Bachelor's Degree in Pharmacy
- Minimum 5-7 years experience in the same industry
- Excellent knowledge in MHRA /FDA regulations.
- Good knowledge about MOH Kuwait rules and regulations
- Ability to appropriately identify and resolve regulatory issues, and communicate as needed to the Management
- Strong leadership
- Good interpersonal skills
- Excellent Analytical skills
- Valid Kuwait residency and driving license
- Bilingual : Arabic & English
Interested candidates can send their CV to Type: Full-time