56 Financial Regulations jobs in Bahrain

• Develop, implement, and maintain robust compliance programs across the organization.
• Monitor regulatory changes and assess their impact on the institution's operations.
• Conduct regular internal audits and risk assessments to identify and mitigate compliance vulnerabilities.
• Investigate potential compliance breaches and recommend corrective actions.
• Develop and deliver compliance training programs for employees at all levels.
• Ensure adherence to all applicable laws and regulations, including AML, KYC, and data privacy requirements.
• Prepare compliance reports for senior management and regulatory bodies.
• Liaise with external auditors and regulatory agencies during examinations.
• Advise business units on compliance matters and provide guidance on new products and services.
• Maintain up-to-date knowledge of the financial services industry and evolving regulatory landscape.

• Bachelor's degree in Law, Finance, Accounting, Business Administration, or a related field. Master's or professional certification (e.g., CAMS, CRCM) preferred.
• 7+ years of experience in a compliance role within the banking or financial services sector.
• In-depth knowledge of financial regulations, including AML, KYC, sanctions screening, and corporate governance.
• Proven experience in conducting compliance audits and risk assessments.
• Strong analytical and problem-solving skills with a high level of attention to detail.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in using compliance management software and tools.
• Ability to work independently and as part of a team in a demanding environment.
• High ethical standards and integrity.
• Experience with regulatory reporting.

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.

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:

• Prepare and apply for the permit document as per the NHRA guidelines and verify the items being imported and the documents required.
• Apply for the NHRA regulated products permits on the NHRA website as per the specified guidelines.
• 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 vehicles, warehouse cleanliness, temperature control mechanism, storage conditions and validity of goods on shelves on a regular basis.
• Ensure all Zahrawi Cold Vans/Delivery Vehicles, Data Loggers are calibrated regularly and update the temperature mapping of the Warehouse.
• Ensure all required licenses and registrations as well as calibration renewals are updated before their expiry dates.
• Review all technical and quality agreements with suppliers and customers on a regular basis.

Warehouse Quality Check:

• Ensure that the Warehouse & Service Room are kept clean and organized.
• Ensure that the temperature control mechanism and hygiene standards are maintained in the Warehouse.
• Ensure a quick and accurate release of shipments from NHRA to avoid any delays in transporting the products to the customer.
• Ensure that all stock areas are segregated properly into: Dispatching, Receiving, Returns, Hold and Expired and that no mix-up could happen at any time.

Product Quality Check:

• Ensure that a sample of each batch of products is secured from the WH Assistants and provide the samples along with a progress report and supplier invoice to the Warehouse Operation, QA & RA Manager for NHRA release approval.
• Check all shipments leaving the Warehouse are sealed and packed properly and if the vehicle is fit for transporting the products.
• Compile all Quality Inspection Forms prepared by the Sr. Driver & Fleet Coordinator and prepare a monthly report.
• Generate a discrepancy report to the Warehouse Operation, QA & RA Manager for MOH release approval for any late findings (excess, damaged or expired goods) in the shipment.

Audit:

• Prepare any documentation needed for internal and external audits.
• File all documents in the corresponding files to ensure all are available and are correct.
• Evaluate the suggestions after the audit and implement them when possible.

Admin:

• Develop a professional relationship with the NHRA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
• Represent Zahrawi in NHRA and different authorities.
• Negotiate with regulatory authorities for marketing authorization.
• Attend and respond to calls and emails from customers, the Sales team and other support staff.
• Assist the Warehouse Coordinators with relevant documents when requested.
• Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to NHRA importation.
• Keep track of all registration application on Zahrawi's tracking system.
• Record all active Zahrawi licenses on the Shared folder and ensure they are updated.

REQUIREMENTS

• Education: Bachelors Degree in Pharmacy
• Additional details:
• Candidates must be based in Bahrain and should be willing to move to company visa (when applicable)
• Candidates must have a valid Pharmacist license
• Experience: 3 + years of relevant experience in regulatory affairs within Bahrain.
• Job Specific Skills: Excellent Interpersonal Skills & Good English – Good computer skills in Ms. Office (Excel– ERP/Oracle system) - Knowledge about Regulatory Affairs, Product Classification and Importation Regulations as per NHRA

Location: Bahrain - Manama

Job Type: FULLTIME

Job Posting Date:

Division/Department: Warehouse Operation and Distribution

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities.
• Maintain a thorough understanding of current and evolving national and international pharmaceutical regulations.
• Liaise with regulatory agencies to facilitate the review and approval process for pharmaceutical products.
• Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
• Monitor regulatory intelligence and assess the impact of new regulations on company products and strategies.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant quality standards.
• Manage post-approval regulatory activities, such as annual reports and safety updates.
• Review and approve promotional materials and labeling to ensure regulatory compliance.
• Participate in regulatory audits and inspections.
• Maintain accurate and organized regulatory databases and filing systems.

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field. A Master's degree is advantageous.
• Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of regulatory submission processes and requirements in key markets.
• Familiarity with ICH guidelines and regional regulatory frameworks.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
• Meticulous attention to detail and a commitment to accuracy.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in regulatory information management systems is a plus.
• Must be able to work effectively within a hybrid model in **Shakhura, Northern, BH**.

• Develop and implement regulatory strategies for new and existing products/services in alignment with global compliance standards.
• Prepare, review, and submit regulatory documentation to relevant authorities (e.g., FDA, EMA, local regulatory bodies).
• Interpret and communicate complex regulatory requirements to internal teams, including R&D, product development, and marketing.
• Monitor changes in regulatory landscapes and proactively assess their impact on the company's operations and product portfolio.
• Act as the primary point of contact with regulatory agencies, managing communications and addressing inquiries.
• Conduct regulatory audits and ensure internal compliance with established procedures and guidelines.
• Identify potential regulatory risks and develop mitigation strategies.
• Collaborate with cross-functional teams to ensure product development and manufacturing processes adhere to regulatory standards.
• Maintain accurate and organized regulatory records and databases.
• Contribute to the development of regulatory policies and standard operating procedures (SOPs).
• Provide training and guidance to internal stakeholders on regulatory matters.
• Support post-market surveillance activities and manage regulatory reporting requirements.

• Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
• Minimum of 6 years of progressive experience in regulatory affairs, preferably within the (mention relevant industry) sector.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of global regulatory requirements and guidelines pertinent to our industry.
• Excellent understanding of product lifecycle management and associated regulatory considerations.
• Strong analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to present complex information clearly and persuasively.
• Proficiency in regulatory information management systems and relevant software.
• Ability to work independently, manage priorities effectively, and meet tight deadlines in a remote environment.
• Detail-oriented with a high degree of accuracy.
• Experience in international regulatory affairs is a significant advantage.

• Develop and execute regulatory strategies for product development and registration, encompassing global markets.
• Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities such as the FDA, EMA, and others.
• Interpret and communicate regulatory requirements and guidelines to internal teams.
• Manage post-approval regulatory activities, including amendments, supplements, and annual reports.
• Conduct regulatory intelligence activities to stay abreast of evolving regulations and advise the company accordingly.
• Liaise with regulatory agencies during the review process and respond to queries.
• Ensure compliance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
• Collaborate closely with R&D, quality assurance, clinical operations, and commercial teams.
• Develop and maintain regulatory documentation and databases.
• Provide training on regulatory compliance to relevant personnel.
• Participate in regulatory audits and inspections.

• Bachelor's degree in a life science, chemistry, pharmacy, or related field; advanced degree preferred.
• Minimum of 6 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Proven success in preparing and filing successful regulatory submissions for drugs or medical devices.
• In-depth knowledge of international regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
• Strong understanding of the drug development process and relevant scientific disciplines.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Exceptional attention to detail and organizational skills.
• Proficiency in regulatory information management systems.
• Ability to work independently and collaboratively in a remote team environment.
• Strong problem-solving skills and strategic thinking.