Overview
regulatory affair officer Jobs in Beirut, Beirut Governorate, Lebanon at FDC (Food & Drug Corporation)
Title: regulatory affair officer
Company: FDC (Food & Drug Corporation)
Location: Beirut, Beirut Governorate, Lebanon
Role Purpose:
§ The Regulatory Affairs Pharmacist is responsible of following up on Pharma business regulatory issues in the Ministry of Health, NSFF.
Key Accountabilities
Prepares applications for the registration of pharmaceutical drugs in Lebanon (MOH registration files), including the preparation of comparative market studies and product scientific summaries.
Follows up on daily/weekly basis on outstanding issues with MOH officials (pending registrations, price changes, etc.)
Assures the coordination and adaptation of foreign procedures to local regulatory requirements.
Joins the MOH officials in their inspection of imports and ensures proper compliance with the pharmaceutical Lebanese regulations.
Assumes all authorities outlined in the authorities schedule.
Undertakes any other duties assigned by his direct superior.
Prepares all related files and documents for product registration.
Registers new products at the Ministry of health.
Updates all files of all existing and registered products.
Prepares all documents with MOH for clearing shipments via sea or air freight.
Inspects all pharmaceutical products with the MOH during the clearing process.
Updates the company with any regulatory changes at the MOH.
Qualifications:
§ Bachelor’s Degree in Pharmacy
§ Member in the Pharmacists Syndicate
Experience:
§ 0-3 years in a similar position
Skills and Knowledge:
§ Languages: English & Arabic. French is a plus.
§ Computer literacy: MS Windows applications.
Competencies:
§ Adhering to Principles and Values
§ Following Instructions and Procedures
§ Working with People
§ Persuading and Influencing
§ Delivering Results and Meeting Customer Expectations
§ Adapting and Responding to Change
§ Achieving Personal Work Goals and Objectives
