Regulatory Affairs Executive

6 days ago


Manama, Bahrain Zahrawi Medical Full time

**About Zahrawi Group**:
Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

**job Brief**: The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time.

**ACCOUNTABILITIES**

**Policies & Procedures**:

- Adhere to all Zahrawi Policies & Procedures as applicable.

**Regulatory Affairs**:

- Ensure that Zahrawi’s products comply with the regulations of the NHRA.
- Keep up to date with the latest changes in regulatory legislation and guidelines.
- Liaise and negotiate with regulatory authority to ensure a smooth registration process.
- Provide advice about regulations to customers/suppliers.
- Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

**Importation Permits**:

- Register and submit the permits for SCE when required.
- Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
- Prepare daily report regarding the rejections/ delays for NHRA importation permits and reasons related to that.

**Importation Rules & Regulations**:

- Communicate with the existing and new suppliers regarding NHRA importation rules and policies.
- Upload on the NHRA importation system any new classifications or registration certificates.
- Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
- Report any deviation from NHRA guidelines of imported shipments and take the corrective and preventive action accordingly.
- Review on a regular basis the NHRA importation process of distribution agreements.
- Ensure that the NHRA license is renewed before expiry date to avoid importation disturbance.
- Segregate the imported products as per HS code in coordination with logistic team and confirm if products are NHRA regulated or not.
- Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

**Pharmacovigilance**:

- Act as the LRPPV (Local Responsible Person for Pharmacovigilance).
- Perform regulatory intelligence by screening the NHRA websites on a weekly basis.
- Screen all scientific and medical literature to stay up to date with the latest regulations.
- Comply with local regulatory requirements for reporting adverse drug reactions and submission of safety reports.
- Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance)
- Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
- Fill the Council for International Organizations of Medical Sciences (CIOMS) forms with all the information collected from the ADRs.
- Send all CIOMS forms to the Manufacturers and the relevant authorities.
- Manage the Pharmacovigilance process of Zahrawi by and prepare all SOPs, product safety reviews and literature reviews when needed.
- Maintain a high level of standard to ensure that all work is moving smoothly and that there are no delays.
- Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.
- Prepare all Registration and Pharmacovigilance forms and communicating the same to the Suppliers and stakeholders.
- Provide trainings to all internal divisions on the current Pharmacovigilance Policies & Procedures.

**Individual Case Study Reports (ICSRs)**:

- Report any spontaneous Individual Case Study Reports (ICSRs) to the Supplier and the Health Authority.
- Maintain a soft and hard copy of all ICSRs for the future.
- Track and follow up with all active ICSR reconciliation with the respective authorities.
- Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.

**Product Classification & Registration**:

- Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
- Prepare all required documents to be submitted for Product Classification under NHRA.
- Prepare all required documents to be submitted for Manufacturing Site registration under NHRA.
- Prepare all the Dossiers to be submitted to NHRA for product registration.
- Collect all necessary documents from Supplier to submit for Health Authorities.

**Quality Assurance**:

- Monitor all Cold Products from point of receiving until delivery of products to customers along with Data Logger results within the set temperature limits.
- Examine the packing of goods from the cold storage and monitor the Data Logger Report to ensure consistency.
- Check the quality of the



  • Manama, Bahrain RAY-CRO Full time

    **Role Description** This is a part-time remote role for a Regulatory Affairs Consultant. The Regulatory Affairs Consultant will be responsible for providing advice on all aspects of regulatory affairs for clinical trials and marketing authorizations, developing and reviewing regulatory documents (e.g. protocols, investigator brochures, informed consent...


  • Manama, Bahrain MedSource W.L.L Full time

    **Responsibilities** - Remain up to date on all new regulations and circulars from NHRA - Obtaining approvals from NHRA for all upcoming shipments - Manage complex negotiations with senior-level NHRA executives - Maintain record of all communications with NHRA officials **Qualifications** - 3+ years' experience as RAO in Bahrain. - NHRA RAO Exam completion...

  • Corporate Lawyer

    11 hours ago


    Manama, Bahrain Alzayani Investments Full time

    Duties & Responsibilities: - Coordinates all cases with Manager, Legal Affairs related to Partners & Divisions. - Reviews & follows up all cases filed by & against AZI & Partners through the Prosecution Court, Executive Court and records all hearings dates with decisions systematically. - Follows up on all hearings and cases at the all Courts and Police...


  • Manama, Bahrain Mega Tech Full time

    Knowledge of Local, state, and federal legislative and executive processes Knowledge of Public affairs principles and practices Knowledge of Project management and planning principles and practices Developing and maintaining relationships with public officials and their staffs Developing and implementing strategic plans as well as responding to short-term...

  • Executive Secretary

    11 hours ago


    Manama, Bahrain Leo International HR Consultancy Full time

    The Role **Requirements**: **Education and Legal Background**: - Bachelor's degree in Law (LLB) or equivalent legal qualification. - Familiarity with corporate governance principles, legal compliance, and regulatory requirements. Experience: - 3-5 years of relevant experience as an executive secretary, legal assistant, or similar role. - Experience in...

  • Legal Advisor

    11 hours ago


    Manama, Bahrain Alzayani Investments Full time

    **Purpose of the Job**: - To assist the Group Manager, Legal Affairs and follow-up all the cases and proceedings at the Bahrain Courts, Public Prosecution and all other Governmental Organization. - Ensure an acceptable standard of Quality Management System is maintained in accordance with recognized working practice and the company’s Quality Manual and...


  • Manama, Bahrain Career Maker Full time

    Sales Executive (Real Estate) Job Description Job Responsibilities: - Develop and implement sales strategies to increase real estate sales and achieve targets. - Conduct market research to identify new business opportunities and trends in the real estate sector. - Build and maintain relationships with potential clients through networking and cold...


  • Manama, Bahrain Crypto.com Full time

    This role will be responsible for managing interactions with regulators, auditors and other external parties, ensuring timely submission of accurate reports and maintaining compliance with all relevant financial regulations. **Responsibilities**: - Prepare and maintain operating budgets, local accounting and reconciliation mechanisms and manage and oversee...


  • Manama, Bahrain Boot camp gym Full time

    a) Execute Fraud Risk Assessments as per methodology. b) Adhere to periodic fraud risk assessments plan. c) Identify, document and communicate fraud risks and control (preventive, detective and corrective) to stakeholders and obtain confirmation. d) Agree on control testing mechanism, frequency with stakeholders in alignment with bank’s operational Risk...


  • Manama, Bahrain Bank ABC Full time

    Assistant to Board Secretary **Job Purpose** To provide assistance to the Board Secretary in relation to all matters in connection with the Company Secretariat function and to assist on additional matters that may arise from time to time. **Principal Responsibilities, Accountabilities and Deliverables of Role** - Assist the Board Secretary with...

  • Project Manager

    6 days ago


    Manama, Bahrain B7 Consultancy Full time

    Overall project planning, schedule and executing the delivery of projects within time, budget and Client’s expectations. - Monitoring progress and identifying critical activities to expedite smooth progress of works on site to meet targets. - Coordinate internal resources and third parties/vendors e.g. Consultants and Sub - Contractors/Suppliers for the...


  • Manama, Bahrain Binance Full time

    Binance is the leading global blockchain ecosystem and cryptocurrency infrastructure provider whose suite of financial products includes the world’s largest digital-asset exchange. Our mission is to accelerate cryptocurrency adoption and increase the freedom of money. If you’re looking for a fast-paced, mission-driven organization where opportunities...

  • Corporate Finance

    11 hours ago


    Manama, Bahrain Bank kp Full time

    **Position**:Senior Consultant **Service Line**:Management Consulting **Educational Qualifications**: Bachelor’s Degree in accounting/ finance/ management and Professional Qualification ACCA/CFA/CPA/Lean Six Sigma **Responsibilities** **Technical**: - Assist with planning and execution of MC engagements in line with professional standards, including...


  • Manama, Bahrain HSBC Full time

    -Job description **Application Support Analyst (Bahraini National)** **Some careers grow faster than others.*** If you’re looking for a career that will give you plenty of opportunities to develop, join HSBC and your future will be rich with potential. Whether you want a career that could take you to the top, or simply take you in an exciting new...


  • Manama, Bahrain The 1 Percent Full time

    The CFO will be responsible for overseeing the financial operations of the company, guiding its financial strategy, planning, and maintaining its fiscal stability. They will collaborate with the executive management team to establish long-range goals, strategies, plans, and policies. The duties include tracking cash flow and financial planning as well as...


  • Manama, Bahrain Talent Pal Full time

    The CFO will be responsible for overseeing the financial operations of the company, guiding its financial strategy, planning, and maintaining its fiscal stability. They will collaborate with the executive management team to establish long-range goals, strategies, plans, and policies. The duties include tracking cash flow and financial planning as well as...


  • Manama, Bahrain RAFFLES Full time

    **Company Description** Introducing Raffles Al Areen Palace Bahrain, an extraordinary addition to Raffles Hotel's renowned portfolio. This ultra-luxury property offers a unique experience as "The Palace of the Secret Garden." With 78 private pool villas ranging from 1 to 3 bedrooms, Raffles Al Areen Palace Bahrain redefines luxury hospitality in Bahrain. Our...


  • Manama, Bahrain Green Innova Full time

    Identify and target potential clients, including financial institutions, fintech companies, and other organizations. - Conduct market research to identify emerging trends, customer needs, and competitive offerings. - Build and nurture relationships with decision-makers and stakeholders in target organizations. - Deliver compelling presentations and...

  • CEO

    11 hours ago


    Manama, Bahrain Domo Ventures W.L.L. Full time

    Our Client, a prestigious luxury jeweler with over 13 boutiques in the GCC and a growing presence in the USA, is looking to fill in the CEO position. **Position Summary**: As the CEO, you will lead the company's strategic direction, oversee operations, and ensure financial health. This role requires a seasoned leader with extensive experience in luxury...

  • Management Consultant

    11 hours ago


    Manama, Bahrain Domo Ventures W.L.L. Full time

    **Management Consultant Business Transformation** **Job Summary** **Responsibilities and Duties** - Develop and execute a comprehensive business transformation strategy aligned with the client's vision and objectives. - Conduct in-depth assessments of the client's operations, financial performance, and organizational structure to identify areas for...