9 Regulatory Requirements jobs in Bahrain

• Preparing and compiling regulatory submissions for new product registrations and variations.
• Liaising with regulatory authorities (e.g., NHRA in Bahrain) regarding product approvals.
• Ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines.
• Reviewing promotional materials for regulatory accuracy.
• Keeping abreast of changes in pharmaceutical regulations and guidelines.

• Prepare, compile, and submit high-quality regulatory dossiers for new product registrations, variations, renewals, and other regulatory activities in compliance with local (NHRA - National Health Regulatory Authority of Bahrain) and international guidelines.
• Act as a primary point of contact for interactions with regulatory authorities, addressing inquiries, and managing communication effectively to expedite approvals.
• Provide expert regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing, ensuring regulatory considerations are integrated throughout the product lifecycle.
• Review and approve labeling, packaging, and promotional materials to ensure full compliance with approved product information and regulatory requirements.
• Monitor and interpret evolving pharmaceutical regulations, guidelines, and legislation in Bahrain and the GCC region, assessing their impact on company products and operations.
• Maintain and update regulatory databases and tracking systems to ensure accurate record-keeping of all submissions, approvals, and correspondence.
• Participate in regulatory intelligence gathering, contributing to strategic planning for future product development and market access.
• Support regulatory inspections and audits, preparing necessary documentation and assisting in responses to findings.
• Collaborate with global regulatory teams to ensure consistent application of regulatory strategies.

• Bachelor's degree in Pharmacy, Pharmacology, Life Sciences, or a related scientific discipline.
• 3+ years of experience in regulatory affairs within the pharmaceutical or healthcare industry, preferably with experience in the GCC market.
• Strong understanding of regulatory requirements for drug registration and post-market activities (e.g., ICH guidelines, GCC regulations, NHRA requirements).
• Excellent written and verbal communication skills, with meticulous attention to detail and accuracy.
• Ability to interpret complex scientific and regulatory data.
• Proficiency in regulatory submission software and Microsoft Office Suite.
• Strong organizational and project management skills, with the ability to manage multiple priorities.
• Ability to work independently and collaboratively in a fast-paced environment.

• Health and dental insurance
• Paid time off
• Opportunities for professional development and specialized regulatory training.
• Performance bonuses and career progression within a global pharmaceutical company.
• A collaborative and intellectually stimulating work environment.

Our client, a prominent pharmaceutical company dedicated to bringing innovative healthcare solutions to market, is actively seeking a meticulous and knowledgeable Regulatory Affairs Specialist to join their vital compliance team. This strategic opportunity is based in Sanad, Capital, BH , offering a chance to navigate complex regulatory landscapes and ensure product market access. We are looking for a detail-oriented and proactive professional who is eager to ensure adherence to global and local pharmaceutical regulations and thrive in a highly dynamic and impactful environment.

As a Regulatory Affairs Specialist , you will play a pivotal role in preparing, submitting, and managing regulatory dossiers for pharmaceutical products throughout their lifecycle. Your expertise will be crucial in interpreting regulatory guidelines, ensuring compliance with health authority requirements, and acting as a key liaison with regulatory bodies. This position demands a deep understanding of pharmaceutical development processes, exceptional documentation skills, and the ability to critically review scientific data. You will be instrumental in securing product approvals, maintaining product licenses, and mitigating regulatory risks, directly contributing to the company's ability to deliver life-saving medicines to patients.

• Prepare and compile comprehensive regulatory submissions (e.g., dossiers, variations, renewals) for new and existing pharmaceutical products in accordance with local and international guidelines (e.g., GCC, ICH, CTD/eCTD).
• Liaise effectively with health authorities (e.g., NHRA in Bahrain) to facilitate product registrations and resolve regulatory queries.
• Stay abreast of changes in pharmaceutical regulations, guidelines, and industry standards, assessing their impact on product development and registration strategies.
• Provide expert regulatory advice and guidance to internal teams (e.g., R&D, manufacturing, marketing) on product development, labeling, and promotional materials.
• Manage and maintain regulatory databases and documentation systems to ensure accuracy and compliance.
• Ensure timely submission of all regulatory documents and responses to health authority queries.
• Conduct regulatory intelligence activities to support strategic planning and risk assessment.
• Participate in cross-functional project teams, representing the regulatory affairs function.
• Assist in the preparation for and participation in regulatory inspections and audits.
• Review product labeling, packaging, and promotional materials for regulatory compliance.

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related scientific field.
• Minimum of 3-5 years of proven experience in regulatory affairs within the pharmaceutical industry.
• Strong understanding of drug development processes, regulatory frameworks in Bahrain/GCC, and international guidelines (e.g., ICH, CTD/eCTD).
• Experience in preparing and submitting regulatory dossiers for product registration and lifecycle management.
• Excellent attention to detail and strong organizational skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory requirements.
• Ability to interpret scientific data and regulatory texts accurately.
• Proficiency in electronic document management systems and Microsoft Office Suite.
• Strong problem-solving skills and ability to work independently and collaboratively.

• Competitive annual salary and comprehensive benefits package.
• Opportunities for professional development and continuous learning in regulatory science.
• A challenging and impactful role within a leading pharmaceutical company.
• Exposure to diverse product portfolios and complex regulatory challenges.
• A supportive and collaborative team environment.
• Clear pathways for career advancement within regulatory affairs.

Our client is committed to ensuring regulatory compliance and bringing safe and effective medicines to patients, fostering a culture of scientific integrity and ethical practices. They are known for their robust regulatory strategies, strong relationships with health authorities, and dedication to patient well-being. If you are a highly meticulous and strategic individual with a passion for regulatory affairs in pharmaceuticals and meet the qualifications outlined above, we encourage you to apply for this vital role.

To apply for this rewarding position, please submit your updated resume and a detailed cover letter outlining your regulatory affairs experience, specific submission types you've managed, and why you are the ideal candidate for this Regulatory Affairs Specialist role. We thank all applicants for their interest; however, only those selected for an interview will be contacted.

• Plan, coordinate, and monitor clinical trials according to study protocols and regulatory guidelines.
• Ensure adherence to Good Clinical Practice (GCP), local regulations, and Standard Operating Procedures (SOPs).
• Conduct site visits, source data verification, and ensure data integrity.
• Manage essential trial documents and maintain accurate records.
• Collaborate with investigators, research staff, and sponsors.
• Identify and resolve issues related to trial conduct, patient safety, and data quality.
• Prepare study reports, summaries, and presentations for internal and external stakeholders.

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related health-scientific field.
• 1-3 years of experience as a Clinical Research Associate or in a similar clinical research role.
• Strong knowledge of ICH-GCP guidelines and relevant regulatory requirements.
• Excellent organizational skills and attention to detail for data collection and documentation.
• Ability to travel to clinical sites as required.
• Strong communication and interpersonal skills to interact with investigators and study staff.
• Proficiency in using Electronic Data Capture (EDC) systems and clinical trial management software.

• Assist in the preparation and compilation of regulatory dossiers and documentation for new product registrations, variations, and renewals.
• Ensure all submissions meet the requirements of the National Health Regulatory Authority (NHRA) in Bahrain and other relevant authorities.
• Maintain and update regulatory databases and tracking systems with accurate information on product registrations and approvals.
• Support the team in responding to queries from regulatory authorities in a timely and efficient manner.
• Review and verify the accuracy of labeling, packaging inserts, and promotional materials to ensure regulatory compliance.
• Keep abreast of changes in local and international pharmaceutical regulations and guidelines.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to gather necessary information for submissions.
• Organize and archive regulatory documents, ensuring easy retrieval and compliance with internal retention policies.
• Assist in the preparation for regulatory inspections and audits.
• Perform administrative tasks as needed to support the regulatory affairs department.

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
• 0-2 years of experience in regulatory affairs, preferably within the pharmaceutical or healthcare industry.
• Basic understanding of pharmaceutical regulatory requirements and guidelines (e.g., GCC, ICH guidelines) is a plus.
• Exceptional attention to detail and strong organizational skills.
• Excellent written and verbal communication skills in English and Arabic.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team in a structured environment.
• Strong analytical and problem-solving abilities.
• Proactive and eager to learn about complex regulatory frameworks.

• Lead the preparation and submission of comprehensive regulatory applications (e.g., CTD/eCTD submissions) for new drug products, variations, and renewals to local and international health authorities.
• Interpret and apply complex regulatory guidelines and provide strategic advice to internal stakeholders, including R&D, Manufacturing, and Quality Assurance teams.
• Act as the primary liaison with regulatory agencies, managing all correspondence and interactions to facilitate timely approvals.
• Monitor and analyze the evolving regulatory landscape, identifying potential impacts on company products and operations, and recommending proactive strategies.
• Ensure all product labeling, promotional materials, and packaging comply with regulatory requirements.
• Conduct regulatory intelligence activities to keep abreast of changes in legislation and best practices within the pharmaceutical industry.
• Participate in cross-functional teams to support product development and commercialization strategies from a regulatory perspective.
• Develop and implement robust internal Standard Operating Procedures (SOPs) for regulatory processes.
• Train and mentor junior regulatory affairs staff, fostering a culture of continuous learning and compliance.
• Manage regulatory databases and documentation systems to ensure accuracy and accessibility of critical information.
• Support internal and external audits by providing necessary documentation and expertise.

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field. A Master’s degree is preferred.
• Minimum of 5-7 years of progressive experience in regulatory affairs within the pharmaceutical industry, with a strong focus on drug product registration in the MENA region.
• In-depth knowledge of local and international pharmaceutical regulations (e.g., ICH guidelines, GCC regulations).
• Proven track record of successful regulatory submissions and approvals.
• Excellent written and verbal communication skills in English and Arabic.
• Strong analytical, organizational, and problem-solving abilities.
• Ability to work independently and as part of a multidisciplinary team in a fast-paced environment.
• Proficiency in regulatory software and documentation management systems.

• Prepare, compile, and submit high-quality regulatory dossiers (e.g., CTD/eCTD) for new drug applications, variations, and renewals.
• Act as the primary contact point for regulatory agencies regarding product registrations and related matters.
• Monitor and interpret changes in local and international pharmaceutical regulations and advise internal stakeholders accordingly.
• Develop and implement regulatory strategies for new product development and lifecycle management.
• Review and approve labeling, promotional materials, and packaging inserts for regulatory compliance.
• Ensure timely submission of all required regulatory documents and maintain accurate records.
• Participate in cross-functional project teams, providing expert regulatory guidance and support.
• Conduct regulatory intelligence activities to anticipate future regulatory requirements and trends.
• Manage and respond to deficiency letters and regulatory inquiries efficiently.
• Support internal and external audits related to regulatory compliance.
• Train and mentor junior regulatory affairs staff as needed.

• Minimum 7 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related scientific field (Master's preferred).
• In-depth knowledge of local (Bahrain/GCC) and international regulatory guidelines (e.g., ICH, FDA, EMA).
• Proven experience in preparing and submitting CTD/eCTD formats.
• Strong understanding of drug development processes and quality management systems.
• Excellent analytical, organizational, and problem-solving skills.
• Exceptional written and verbal communication skills in English, with Arabic being a significant advantage.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• High level of attention to detail and accuracy.
• Proficiency in regulatory databases and document management systems.

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.