وظيفة نائب مدير الشؤون التنظيمية في شركة المعجل للأدوية في الكويت

Regulatory Affairs Deputy Manager
About the job
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 57 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
Interested candidates can send their CV to [email protected]


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