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regulatory affairs coordinator

Jamjoom Pharma

<div><p><b>About the Role</b><br>
Support the registration, maintenance, and compliance of pharmaceutical products with the SFDA and regional health authorities&mdash;driving timely submissions, approvals, and adherence to all regulatory requirements.</p><p></p><p><b><br>
Key Responsibilities</b></p><ul><li>
Manage product registrations, renewals, variations, and pricing submissions to SFDA and GCC authorities.</li><li>
Serve as the primary liaison with SFDA for Scientific Office and Regulatory Affairs communications, including handling and closing authority queries.</li><li>
Oversee market maintenance obligations, such as shortage notifications and related compliance requirements.</li><li>
Ensure compliance of both promotional and non-promotional activities (materials, events, digital content) with SFDA regulations.</li><li>
Coordinate with QA, Medical, Marketing, and Supply Chain teams to collect documentation, support submissions, and maintain accurate records and archives.</li><li>
Monitor regulatory updates and translate them into practical internal actions (e.g., SOPs, templates, brief trainings).</li></ul><p></p><p><b><br>
Qualifications</b></p><ul><li>
BSc Pharmacy / PharmD</li><li>
1&ndash;3 years of Regulatory Affairs experience in the Saudi market; export market exposure is a plus.</li><li>
Familiarity with Scientific Office obligations and SFDA e-services; working knowledge of eCTD/RIM is an advantage.</li><li>
Strong organization, attention to detail, and stakeholder communication (Arabic &amp; English).</li></ul><p>
Regards,</p></div><p></p>

Regulatory Affairs Specialist

SERVIER

<div></div><div><div><div><div><div><b>Date posted: </b>Sep 10, 2025
</div></div></div></div><div><div><div><div><b>City: </b>Riyadh
</div></div></div></div><div><div><div><div><b>Country/Region: </b>SA
</div></div></div></div><div><div><div><div><b>Type of Contract: </b>Full-time Employment / Unlimited
</div></div></div></div><div><div><div><div><b>Job Requisition ID: </b>9758
</div></div></div></div><div></div><div><div><div><div><p>Regulatory Affairs Specialist - KSA
</p></div></div></div></div><div><div><div><div><div>.</div>
<p><b>
Job Purpose</b></p>
<ul>
<li>The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.</li>
<li>Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).</li>
<li>Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.</li>
<li>Collaboration with the local partners, local authorities and WRA in France.</li>
<li>Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.</li>
<li>Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.</li>
<li>Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.</li>
<li>Collaborates closely with the Department Head in all department related tasks and activities.</li>
<li>Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.</li>
<li>Cross functionality &amp; collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.</li></ul><br>
<p></p>
<p><b>
Role Responsibilities</b></p>
<p><b>
Life-Cycle </b><b>management of products</b></p>
<ul>
<li>Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals...</li>
<li>Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.</li>
<li>Follow country specific procedures and SFDA guidelines in the KSA market.</li>
<li>Coordination &amp; liaising with WRA teams/distributors for preparation of all types of regulatory dossiers &amp; local documentation.</li>
<li>Preparation of price forms and related documentation for new product registration files.</li>
<li>Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.</li>
<li>To keep track of the registration status of products with submission, registration, expiry dates.</li>
</ul>
<p><b>Regulatory Tasks</b></p>
<ul>
<li>Closely collaborate with the Head of the Department for all regulatory tasks.</li>
<li>Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.</li>
<li>Involved actively in the budget preparation of KSA Regulatory Affairs.</li>
<li>Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.</li>
<li>Reference standard submissions to the authorities.</li>
<li>Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.</li>
<li>Actively involved in Regulatory Audits.</li></ul><br>
<p></p>
<p><b>
Regulatory Site Management
</b></p><ul><li>For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.</li>
</ul>
<p><b>Other related tasks</b></p>
<ul>
<li>Management/Organizing department supported conferences for Health Authorities in the ME countries.</li>
<li>Liaise closely with agent and Health Authorities in KSA.</li>
<li>Responsible for Change Controls for Variations for the ME region.</li>
<li>Work as a deputy for the local responsible person for advertisement/promotional material.</li>
<li>Deputy Local Responsible person for validation of Packaging Items.</li>
<li>Cross collaboration with other ME departments.</li></ul><br>
<p></p>
<p><b>
Dimensions</b></p>
<ul>
<li>Geographical span: ME - KSA.</li>
<li>Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.</li>
<li>Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.</li>
<li>Work and support the KSA Regulatory Affairs team.</li>
<li>Cross-functionality with other departments.</li>
<li>Report to the Head of the Department.</li></ul><br>
<p></p>
<p><b>
Requirements</b></p>
<p><b>
Educational</b><b> </b><b>qualifications</b></p>
<ul>
<li>Bachelor&rsquo;s Degree in Pharmacy / Science.</li>
</ul>
<p><b>Relevant Experience</b></p>
<ul>
<li>3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.</li>
<li>Experience working in Saudi Arabia (preferred).</li>
<li>Experience of working within a Global pharmaceutical company would be an advantage.</li></ul><br>
<p></p>
<p><b>
Skills &amp; Personal characteristics</b></p>
<ul>
<li>Good knowledge of the Regulatory environment and procedures in KSA.</li>
<li>Sharp Regulatory Intelligence.</li>
<li>Ability to work cross functional to resolve complex issues.</li>
<li>Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.</li>
<li>Multi-tasking, organized, Process &amp; Result oriented, Focused, Problem solving, good judgment and decision-making capability.</li>
<li>Excellent interpersonal, Negotiation and relationship building skills.</li>
<li>Excellent interpersonal, communication &amp; digital skills.</li>
<li>Written and spoken fluency in English &amp; Arabic (French is an added advantage).</li></ul><br>
<div></div>
<div>Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.</div><br>
<div></div>
<div>At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.</div></div></div></div></div></div><p></p>

Regulatory Affairs Specialist - KSA

Zahrawi Medical

<p></p><div><div><div><div><div><h6 class="jobSectionHeader"><b>About Zahrawi Group</b></h6>
<p>Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, &amp; Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, &amp; Analytical Industries.
</p></div><div><h6 class="jobSectionHeader"><b>job Brief</b></h6>
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.
</div><div><div><p>They are also responsible for the preparation of the pre- and final permits for the imported items as per the SFDA guidelines.</p><p><b>
ACCOUNTABILITIES</b></p><p><b>
Policies &amp; Procedures:</b></p><ul><li>
Adhere to all Zahrawi Policies &amp; Procedures as applicable.</li></ul><p><b>
Regulatory Affairs:</b></p><ul><li>
Ensure that Zahrawi&rsquo;s products comply with the regulations of the SFDA.</li><li>
Keep up to date with the latest changes in regulatory legislation and guidelines.</li><li>
Liaise and negotiate with regulatory authority to ensure a smooth registration process.</li><li>
Provide advice about regulations to customers/suppliers.</li><li>
Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.</li></ul><p><b>
Product Classification &amp; Registration:</b></p><ul><li>
Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.</li><li>
Prepare all required documents to be submitted for Product Classification under SFDA.</li><li>
Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.</li><li>
Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.</li><li>
Prepare and submit samples to SFDA for product registration completion.</li><li>
Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.</li><li>
Register reagents with restricted elements through Ghad System.</li></ul><p><b>
Importation Permits:</b></p><ul><li>
Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.</li><li>
Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.</li><li>
Register and submit the permits through Ghad system.</li><li>
Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.</li><li>
Prepare weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that.</li><li>
Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.</li></ul><p><b>
Exportation Permits:</b></p><ul><li>
Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.</li></ul><p><b>
Importation Rules &amp; Regulations:</b></p><ul><li>
Communicate with the existing and new suppliers regarding SFDA importation rules and policies.</li><li>
Upload on the SFDA importation system any new classifications or registration certificates.</li><li>
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.</li><li>
Report any deviation from SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.</li><li>
Review on a regular basis the SFDA importation process of distribution agreements.</li><li>
Ensure that the SFDA license is renewed before expiry date to avoid importation disturbance.</li><li>
Segregate the imported products as per HS code in coordination with logistic team and confirm if products are SFDA regulated or not.</li><li>
Coordinate with the Procurement &amp; Logistics Team to update all the required documents in time to avoid importation rejections.</li></ul><p><b>
Audit:</b></p><ul><li>
Prepare any documentation needed for internal and external audits.</li><li>
File all documents in the corresponding files to ensure all are available and are correct.</li><li>
Evaluate the suggestions after the audit and implement them when possible.</li></ul><p><b>
Admin:</b></p><ul><li>
Assist the Warehouse Coordinators with relevant documents when requested.</li><li>
Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to SFDA importation.</li></ul><p><b>
Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above.</b></p><p><b>
REQUIREMENTS</b></p><ul><li><p><b>
Education:</b> Bachelor&rsquo;s degree (Biology/ Pharmacy/ Biomedical or Science related major is an advantage)</p></li><li><p><b>
Experience:</b> 2-3 years of relevant experience in regulatory affairs</p></li><li><b>
Job Specific Skills:</b> Effective Communication skills &amp; Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel&ndash; ERP/Oracle system) &ndash; Process Management skills &ndash; Detail Oriented &ndash; Knowledge about Saber System &amp; Ghad System - Knowledge in SFDA regulations.</li><li><p><b>
Additional Details:</b> Candidate should be Saudi National and based in Riyadh, KSA.</p></li></ul>
</div></div><p></p><p>Location: KSA - Riyadh
</p><p></p><p>Job Type: FULLTIME
</p><p></p><p>Job Posting Date: 03-09-2025
</p><p>Division/Department: Regulatory Affairs and Pharmacovigilance</p></div></div></div></div><p></p>

Regulatory Affairs Executive/Specialist

NICE ONE

<div><h2 class="jobSectionHeader"><b>Job Purpose:</b></h2><p>
To manage the registration of products with relevant authorities and ensure accurate coordination with internal departments such as supply chain and warehouse to maintain compliance and operational efficiency.</p><h2 class="jobSectionHeader"><b>
Key Responsibilities:</b></h2><ul>
<li><p>
Register and maintain product information in internal systems.</p></li>
<li><p>
Coordinate with the supply chain and warehouse teams to ensure product availability and compliance.</p></li>
<li><p>
Handle product registration processes with:</p><ul>
<li><p>
Saudi Food and Drug Authority (SFDA)</p></li>
<li><p>
Zakat, Tax and Customs Authority (ZATCA)</p></li>
<li><p>
Saudi Customs</p></li>
</ul></li>
<li><p>Maintain organized records of regulatory documentation and approvals.</p></li>
<li><p>
Monitor the status of registration applications and follow up as required.</p></li>
<li><p>
Ensure compliance with applicable local regulatory requirements.</p></li>
<li><p>
Support reporting and documentation related to product registration.</p></li>
</ul><h2 class="jobSectionHeader"><b>
Qualifications &amp; Skills:</b></h2><ul>
<li><p>
Bachelor&rsquo;s degree in Business Administration, Supply Chain, Regulatory Affairs, or a related field.</p></li>
<li><p>
1&ndash;3 years of relevant experience.</p></li>
<li><p>
Familiarity with SFDA, ZATCA, and Customs platforms is preferred.</p></li>
<li><p>
Strong organizational and coordination skills.</p></li>
<li><p>
High attention to detail and data accuracy.</p></li>
<li><p>
Proficiency in Microsoft Office; ERP system knowledge is a plus.</p></li>
<li><p>
Effective communication skills in English and Arabic.</p></li></ul></div>

Registration and Follow up Specialist

Sandoz

<div><ul><li>3 years&rsquo; experience in the regulatory field (new submission/ maintenance activity/ pricing) in assigned market(s).
</li><li>Review and compile the registration dossier in cooperation with the Regulatory Competence Centre (RCC) department and the local relevant stakeholders to fulfil the local requirements and ensure smooth and rapid submission and approval of the files, in a timely manner, in line with the registration planning cascaded by the line manager and DRA Head.
</li><li>Review and Validation of the promotional and educational materials against health authority regulations and approved product information and obtaining the authority approvals when applicable.
</li><li>Communicate the deficiency letters raised by the health authorities to line manager and DRA Head and relevant global stakeholders during evaluation within the specified timeframe.
</li><li>Ensure supply continuity of the registered products by securing the timely submissions and approvals of the variations and requesting special importation permit from HA when needed.
</li><li>Maintain all market artworks in coordination with the labeling responsible and manufacturing site in alignment with the country regulations and approved product information.
</li><li>Ensure execution of Pharmacovigilance and patient safety regulatory activities in compliance with the relevant SOPs and local HA regulations.
</li><li>Ensure that product patient information leaflets are updated according to the latest CDS update approved in the country of origin by securing timely submission in alignment with the relevant SOP.
</li><li>Complete and regular archiving the registration files, authorities correspondence and relevant documents.
</li><li>Monthly reporting of the activity, regular and accurate updating of the tracking tools.
</li><li>Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued by the health authorities, and immediate gap assessment and timely implementation within the company when applicable.
</li><li>Contribution in overall strategy building, planning and execution of market activities to achieve the overall market(s) TGT and objectives.
</li><li>Support in onboarding and guidance of any new joiners in GLS DRA team.</li></ul></div><br><br>

DRA Senior Associate, Gulf

Safwat Al-Khaleej

<p><b>Company: </b>A Leading Healthcare Provider in Riyadh<br/><b>Location:</b> Riyadh, Saudi Arabia<br/><b>Job Type:</b> Full-time, Senior Leadership</p><p><b>About Us</b></p><p>Client is a premier, state-of-the-art medical facility in the heart of Riyadh, renowned for its exceptional patient care, cutting-edge technology, and world-class medical expertise. We are committed to advancing healthcare in the Kingdom of Saudi Arabia through innovation, research, and the highest standards of clinical excellence. As we continue to grow and shape the future of healthcare, we are seeking a visionary and strategic leader to join our executive team as the Director of Medical Affairs.</p><p><b>The Opportunity</b></p><p>This is a unique opportunity to play a pivotal role at the intersection of clinical medicine, administration, and strategic leadership. As the Director of Medical Affairs, you will be the key link between our medical staff and executive management, ensuring the delivery of superior patient care while driving medical governance, quality improvement, and clinical research initiatives. Your work will directly impact our reputation, our patients' outcomes, and the professional development of our medical staff.</p><p><b>Key Responsibilities:</b></p><p><b>Strategic Leadership &amp; Governance:</b></p><ul><li>Develop and execute the medical affairs strategy in alignment with the hospital's overall mission and vision.</li><li>Chair and provide secretariat support to key medical committees (e.g., Medical Advisory, Credentials, Ethics).</li><li>Oversee the implementation and adherence to hospital medical bylaws, rules, and regulations, ensuring compliance with Saudi Council for Health Specialties (SCFHS) and Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) standards.</li><li>Manage the medical staff credentialing, privileging, and re-appointment processes.</li></ul><p><b>Quality &amp; Patient Safety:</b></p><ul><li>Lead hospital-wide quality improvement and patient safety programs in collaboration with the Quality Department.</li><li>Analyze clinical outcomes data, identify trends, and implement initiatives to enhance the quality of care.</li><li>Promote a culture of continuous quality improvement and evidence-based practice among all medical staff.</li></ul><p><b>Medical Staff Management &amp; Development:</b></p><ul><li>Serve as the primary administrative liaison for all physicians, fostering a collaborative and positive working environment.</li><li>Address and mediate professional practice concerns and conflicts.</li><li>Oversee the planning and accreditation of Continuous Medical Education (CME) and professional development programs for medical staff.</li></ul><p><b>Clinical Research &amp; Academia:</b></p><ul><li>Provide strategic direction and administrative support for the hospital's clinical research activities.</li><li>Foster partnerships with academic institutions and promote a research-oriented culture.</li><li>Ensure all research activities comply with ethical guidelines and regulatory requirements.</li></ul><p><b>Regulatory &amp; Accreditation:</b></p><ul><li>Act as the primary point of contact for all matters related to SCFHS and CBAHI.</li><li>Lead the preparation for and ensure successful passage of all national and international accreditation surveys.</li></ul><p><b>Qualifications &amp; Experience:</b></p><p><b>Essential:</b></p><ul><li>Medical Doctor (MD) or Bachelor of Medicine, Bachelor of Surgery (MBBS) degree from an accredited institution.</li><li>Valid SCFHS license and classification as a Consultant (or eligibility for the same).</li><li>Minimum of <b>10 years of post-qualification clinical experience</b>, with at least <b>5 years in a significant medical leadership or medical affairs role</b> within a large, acute care hospital.</li><li>Proven track record in medical governance, quality management, and accreditation processes (CBAHI, JCI, etc.).</li><li>Exceptional understanding of the Saudi Arabian healthcare landscape and regulatory framework.</li><li>Strong financial and budgetary management skills.</li><li>Outstanding leadership, communication, and interpersonal skills with the ability to influence and engage senior stakeholders.</li></ul><p><b>Desirable:</b></p><ul><li>Master's degree in Healthcare Administration (MHA), Business Administration (MBA), or a related field.</li><li>Experience in developing and launching clinical research programs.</li></ul><p>Job Type: Full-time</p>

CMO - Director of Medical Affairs

Malaa

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><b><br>
</b></div><div><b>
Key Responsibilities</b></div><div><b>
1. Legal Affairs</b></div><ul>
<li>Draft, review, and negotiate all types of contracts, agreements, and legal documents to safeguard the company&rsquo;s interests.</li>
<li>Provide legal advice and consultation to management and departments on regulatory compliance, commercial matters, and risk exposure.</li>
<li>Monitor and follow up on complaints and disputes involving the company.</li>
<li>Oversee and manage external legal counsel handling ongoing litigation or legal proceedings.</li>
<li>Ensure internal policies and procedures are legally sound and aligned with applicable laws and regulatory requirements.</li>
<li>Maintain legal documentation to ensure compliance with relevant laws and contractual obligations.</li>
</ul><div><b>2. Corporate Governance</b></div><ul>
<li>Support the preparation and execution of Board of Directors and committee meetings, including drafting agendas, minutes, and resolutions.</li>
<li>Maintain corporate records such as shareholder registers, board resolutions, and official documentation.</li>
<li>Ensure compliance with corporate governance standards and regulatory requirements.</li>
<li>Prepare and submit periodic reports to the Board on key legal, regulatory, governance, and audit-related matters.</li>
<li>Coordinate with internal and external auditors, facilitating information exchange and timely responses from departments.</li>
<li>Follow up on the implementation of audit recommendations and corrective actions, ensuring proper closure and reporting.</li>
</ul><div><b>3. Government Relations</b></div><ul>
<li>Act as a liaison between the company and relevant government entities.</li>
<li>Ensure timely submission of regulatory filings and responses to inquiries or directives.</li>
<li>Monitor regulatory changes and assess their impact on company operations, policies, and reporting obligations.</li></ul><div></div><h3 class="jobSectionHeader"><b><br>
Qualifications &amp; Experience</b></h3><br>
<div></div><ul><li>
Bachelor&rsquo;s degree in Law, Legal Studies, or a related field (Master&rsquo;s degree is an advantage).</li>
<li>3&ndash;5 years of professional experience in legal affairs, corporate governance, or government relations within the financial sector.</li>
<li>Knowledge of Saudi laws, regulations, and guidelines issued by SAMA, CMA, and other regulatory authorities.</li>
<li>Experience in drafting and reviewing contracts, handling disputes, and coordinating with external counsel.</li>
<li>Familiarity with board secretariat functions, governance frameworks, and regulatory compliance reporting.</li>
<li>Proven ability to manage relationships with government bodies and monitor regulatory developments.</li>
<li>Excellent written and verbal communication skills in Arabic and English.</li>
<li>High level of integrity, attention to detail, and ability to manage confidential information.</li>
<li>Sector<b>: </b>Financial Institutions</li>
<li>Saudi Nationals Only</li></ul><div></div><h3 class="jobSectionHeader"><b><br>
About Malaa</b></h3><div>
Malaa is the leading wealth management tool in the Kingdom, addressing the gap in the financial products offerings and advancing cutting-edge technology adoption by offering data-driven financial products and services that empower individuals and organizations for better financial decisions. Established in November 2021, Malaa aims to be the go-to for financial decision-making, whether it&rsquo;s for saving, lending, or investing. Malaa is regulated by the Saudi Central Bank (SAMA) for Open Banking activities and the Capital Market Authority for Robo-advisory and asset management activities.</div><div></div><div><br>
Malaa is spearheading Open Banking in the Kingdom as the first Open Banking company to officially launch its services for its users and the first company to offer behavioral risk profiling for its lending partners, leveraging Open Banking data with exceptional engineering and data science capabilities.</div><div>
<br>
For more information, visit: www.malaa.tech</div></div>

Legal & Governance Officer

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