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Senior Compliance Officer

2 weeks ago

Manama, Manama, Bahrain beBee Careers Full time
Regulatory Affairs Specialist

About the Role

The Regulatory Affairs Executive will be responsible for ensuring that all products comply with the regulations of the National Health Regulatory Authority (NHRA). This includes maintaining up-to-date knowledge of regulatory legislation and guidelines, liaising with the authority to ensure a smooth registration process, and providing advice about regulations to customers and suppliers.

This role also involves analyzing product complaints, making recommendations to solve problems, and preparing daily reports regarding rejections or delays for NHRA importation permits. Additionally, the successful candidate will communicate with existing and new suppliers regarding NHRA importation rules and policies, upload new classifications or registration certificates on the NHRA system, and ensure that all urgent requests from the Sales team and suppliers are dealt with promptly.

In terms of Product Classification and Registration, the incumbent will ensure that all required documents and actions are available, prepare necessary documents for Product Classification and Manufacturing Site Registration under NHRA, and collect all necessary documents from Suppliers to submit for Health Authorities. Furthermore, this role involves performing regulatory intelligence by screening the NHRA websites on a weekly basis, screening all scientific and medical literature to stay updated with the latest regulations, and complying with local regulatory requirements for reporting adverse drug reactions and submission of safety reports.

The Regulatory Affairs Executive will also be responsible for managing the Pharmacovigilance process of Zahrawi, preparing all SOPs, product safety reviews, and literature reviews when needed, maintaining a high level of standard to ensure that all work is moving smoothly, and preparing and reviewing all SOP's Pharmacovigilance plans for all Zahrawi Suppliers.

Moreover, the successful candidate will be responsible for Individual Case Study Reports (ICSRs), including reporting any spontaneous ICSRs to the Supplier and the Health Authority, maintaining soft and hard copies of all ICSRs for future reference, tracking and following up with active ICSR reconciliations with the respective authorities, and reporting all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.

Key Responsibilities

  • Maintain up-to-date knowledge of regulatory legislation and guidelines
  • Liaise with NHRA to ensure smooth registration process
  • Analyze product complaints and make recommendations
  • Prepare daily reports regarding rejections or delays for NHRA importation permits
  • Communicate with suppliers regarding NHRA importation rules and policies
  • Perform regulatory intelligence by screening NHRA websites
  • Screen scientific and medical literature to stay updated with latest regulations
  • Comply with local regulatory requirements for reporting adverse drug reactions

Requirements

  • Bachelor's Degree in Pharmacy
  • Valid Pharmacist license
  • 1+ years of experience in regulatory affairs within Bahrain preferred
  • Good English language skills
  • Excellent interpersonal skills
  • Knowledge of regulatory affairs, product classification, and importation regulations as per NHRA