11 Regulatory Affairs jobs in Bahrain

• Provide expert advice on regulatory compliance and legal requirements in Bahrain and the GCC.
• Assist clients in obtaining licenses, permits, and approvals from relevant authorities.
• Monitor regulatory changes and assess their impact on client businesses.
• Develop and implement compliance programs and policies for clients.
• Conduct regulatory due diligence and risk assessments.
• Prepare and review regulatory submissions and documentation.
• Liaise effectively with government agencies and regulatory bodies.
• Advise on corporate governance and corporate secretarial matters.
• Support legal teams in complex transactions and cross-border dealings.
• Ensure clients adhere to industry-specific regulations and best practices.

• Law degree (LLB or JD) or a relevant degree in Public Administration, Business, or Economics.
• Minimum of 7 years of experience in regulatory affairs, compliance, legal advisory, or corporate governance.
• In-depth knowledge of Bahraini and GCC regulatory environments and business laws.
• Experience in liaising with government authorities and regulatory bodies.
• Strong analytical, research, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and meet demanding deadlines.
• Proficiency in legal research databases and compliance software.
• Understanding of corporate law and company formation procedures.
• Fluency in English is essential; Arabic language proficiency is highly advantageous.

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

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.

• 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.
• 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 requests 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.
• 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 preparing 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 communicate 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.

• Education: Bachelors Degree in Pharmacy
• Candidates must be based in Bahrain.
• Bahraini national is preferred.
• Candidates must have a valid Pharmacist license.
• RAO license is a plus.
• Experience: Fresh graduates or 1+ years of relevant experience in regulatory affairs within Bahrain is preferred.
• 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.

• Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations, renewals) to health authorities.
• Develop and implement regulatory strategies to support product development and commercialization.
• Act as the primary point of contact for regulatory agencies.
• Interpret and communicate regulatory guidelines and requirements to internal teams.
• Ensure compliance of product labeling, packaging, and promotional materials with regulatory standards.
• Conduct regulatory intelligence gathering and analysis to identify potential impacts on the business.
• Manage the lifecycle of approved products, including post-approval changes and reporting.
• Provide regulatory input and support for clinical trial applications.
• Contribute to the development and maintenance of regulatory quality systems.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of pharmaceutical regulatory requirements and guidelines (e.g., ICH, FDA, EMA, SFDA).
• Proven experience in preparing and submitting marketing authorization applications.
• Excellent written and verbal communication skills, with strong attention to detail.
• Strong project management and organizational skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in regulatory information management systems is a plus.

• Develop and implement regulatory strategies for the submission and approval of new pharmaceutical products.
• Prepare, review, and submit regulatory dossiers (e.g., CTD format) to health authorities in accordance with guidelines.
• Ensure ongoing compliance with all relevant pharmaceutical laws, regulations, and guidelines applicable in target markets.
• Manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Liaise with health authorities and regulatory agencies on behalf of the company, addressing queries and facilitating approvals.
• Monitor changes in the regulatory landscape and assess their impact on the company’s products and operations.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, quality assurance, and marketing.
• Oversee the labeling and promotional material review process to ensure compliance with regulatory requirements.
• Manage the regulatory affairs team, providing mentorship, training, and performance management.
• Participate in regulatory audits and inspections.
• Develop and maintain regulatory intelligence databases and knowledge repositories.
• Contribute to the strategic planning and business development initiatives by providing regulatory insights.
• Ensure accurate and timely regulatory documentation is maintained.
• Represent the company in industry forums and regulatory meetings as needed.

• A Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. A Master’s degree or Ph.D. is a strong asset.
• Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs, with a significant portion in a management or senior specialist role.
• In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, SFDA, GCC-DR) and submission processes.
• Proven experience in preparing and submitting successful marketing authorization applications.
• Excellent understanding of drug development, manufacturing, and quality assurance principles.
• Strong analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with meticulous attention to detail.
• Proven leadership and team management capabilities.
• Proficiency in regulatory information management systems and software.
• Fluency in English; Arabic language skills are beneficial.

• Developing and executing regulatory strategies for product registration and lifecycle management in various international markets.
• Preparing and submitting regulatory dossiers (e.g., CTD, NDA, ANDA) to health authorities.
• Reviewing and approving product labeling, promotional materials, and advertising to ensure regulatory compliance.
• Interacting with regulatory agencies, responding to queries, and managing regulatory submissions.
• Monitoring changes in regulatory legislation and guidelines, assessing their impact, and implementing necessary changes.
• Providing regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
• Participating in regulatory inspections and audits.
• Maintaining regulatory databases and tracking submission status.
• Contributing to the development of departmental SOPs and processes.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree or PhD is a plus.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Strong understanding of global regulatory requirements for drug approval (e.g., FDA, EMA, ICH guidelines).
• Proven experience in preparing and submitting regulatory filings.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Proficiency in regulatory information management systems.
• Ability to manage multiple projects and meet tight deadlines.
• Strong analytical and problem-solving abilities.
• Team player with excellent interpersonal skills.
• Experience in specific therapeutic areas is an advantage.

• Develop and execute regulatory strategies for product registration and lifecycle management in target markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, MAA) to health authorities.
• Liaise directly with regulatory agencies to address inquiries and facilitate approvals.
• Ensure ongoing compliance with all applicable regulations, guidelines, and company policies.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Manufacturing, and Marketing.
• Manage post-approval regulatory activities, such as variations, renewals, and labeling updates.
• Conduct regulatory intelligence activities to identify new opportunities and potential risks.
• Maintain and organize regulatory documentation and databases.
• Contribute to the development of company regulatory policies and procedures.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory requirements in key markets (e.g., US FDA, EMA, MENA authorities).
• Proven experience in preparing and submitting regulatory dossiers.
• Strong understanding of pharmaceutical development, manufacturing, and quality systems.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with a strong command of scientific and regulatory terminology.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in regulatory information management systems.
• Attention to detail and a commitment to accuracy.

• Develop, implement, and maintain comprehensive risk management and compliance programs for the institution.
• Ensure adherence to all relevant banking laws, regulations, and guidelines, including AML/CFT requirements.
• Conduct regular risk assessments and identify potential compliance breaches or areas of vulnerability.
• Develop and update internal policies, procedures, and controls to mitigate identified risks.
• Manage the institution's relationship with regulatory authorities, including preparing and submitting required reports.
• Oversee the implementation of AML/CFT policies, including customer due diligence (CDD), transaction monitoring, and suspicious activity reporting (SAR).
• Conduct internal investigations and compliance audits, reporting findings and recommending corrective actions.
• Provide training and guidance to staff on compliance and risk management best practices.
• Monitor changes in the regulatory landscape and advise senior management on their impact.
• Lead and mentor a team of compliance and risk professionals.

• Master's degree in Finance, Law, Risk Management, or a related field. Professional certifications such as CAMS, CRISC, or FRM are highly desirable.
• Minimum of 7 years of experience in banking supervision, risk management, compliance, or internal audit within the financial services sector.
• In-depth knowledge of financial regulations, particularly those related to AML, CFT, and prudential supervision in the GCC region.
• Proven experience in developing and implementing compliance frameworks and risk assessment methodologies.
• Strong analytical and problem-solving skills with the ability to interpret complex regulations.
• Excellent communication, presentation, and interpersonal skills, with the ability to interact effectively with regulators and senior management.
• Demonstrated leadership and team management capabilities.
• Proficiency in risk management software and Microsoft Office Suite.
• High level of integrity and professional ethics.

• Develop, implement, and manage the organization's Safety Management System (SMS).
• Conduct regular safety audits, inspections, and risk assessments across all operational areas.
• Investigate aviation incidents, accidents, and near misses, identifying root causes and recommending corrective actions.
• Develop and deliver safety training programs to all levels of staff.
• Ensure compliance with all applicable national and international aviation safety regulations.
• Review and update safety policies, procedures, and manuals as necessary.
• Promote a strong safety culture throughout the organization.
• Liaise with regulatory authorities and industry bodies on safety matters.
• Analyze safety data to identify trends and proactively mitigate risks.
• Prepare safety reports and recommendations for management.

• Bachelor's degree in Aviation Management, Aerospace Engineering, or a related field.
• Minimum of 5 years of experience in aviation safety management or a related role.
• Proven experience in developing and implementing Safety Management Systems (SMS).
• In-depth knowledge of aviation regulations and standards (e.g., ICAO Annex 19, relevant national regulations).
• Experience with incident investigation and root cause analysis techniques.
• Strong understanding of risk management principles in the aviation context.
• Excellent analytical, communication, and presentation skills.
• Ability to work independently and collaboratively with cross-functional teams.
• Strong leadership and influencing skills.
• Proficiency in safety management software is a plus.