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regulatory affairs specialist

Ray-CRO

<p>We&rsquo;re Hiring: Regulatory Affairs Specialist</p><p>On behalf of a leading multinational pharmaceutical company</p><p>A renowned multinational pharmaceutical company is seeking a talented and motivated Regulatory Affairs Specialist to join its dynamic regional team.</p><p>If you have solid experience with GCC regulatory submissions and a passion for ensuring compliance in a fast-paced, innovative environment &mdash; we want to hear from you!</p><p>Key Responsibilities:</p><p>Prepare and submit registration dossiers in line with GCC health authority requirements (SFDA, DHA, NHRA, etc.).</p><p>Maintain up-to-date knowledge of regulatory guidelines and legislation across GCC countries.</p><p>Collaborate with cross-functional teams to ensure timely and accurate submissions.</p><p>Support product lifecycle activities including renewals, variations, and labeling compliance.</p><p>Communicate effectively with regional regulatory bodies and internal departments.</p><p>Qualifications:</p><p>Bachelor&rsquo;s degree in Pharmacy, Life Sciences, or a related field.</p><p>Strong understanding of regional regulatory frameworks.</p><p>Excellent organizational and communication skills.</p><ul><li>3-5 years GGC experience ,</li><li>eCTD knowledge (compiling and lifecycle management using any eCTD tools )</li><li>Excellent communication and documentation skills</li><li>Attention to detail and analytical thinking</li><li>Proficiency in English and Arabic</li></ul><p>Job Types: Full-time, Part-time</p>

Regulatory Affairs Specialist

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

Mundipharma

<div>ARA-P3-12<div>
Regulatory Affairs TSO Manager</div><div></div><div>
Location: Riyadh, KSA</div><div>
Department: Regulatory Affairs</div><div>
Job type: Permanent</div><div></div><div>
Join us and make a difference when it matters most!</div><div>
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.</div><div></div><div>
The Team</div><div>
The role will join the Regulatory Affairs team in Riyadh, accountable for the regulatory affairs in Saudi, driving optimal regulatory outcomes and ensuring governance on regulatory activities. You will support PV Operations leadership as needed and act as TSO manager in KSA on behalf of the company.</div><div></div><div>
Role and Responsibilities</div><ul><li>
Ensure full compliance to all local and international regulations, codes and standards and company SOP.</li><li>
Prioritize assignments between RA and TSO aspects of role and co-ordinate multiple projects and activities accordance with company objectives.</li><li>
Be responsible for regulatory submissions and responses to deficiency letters, and timely tracking status of the progress, including new product registration, line extensions, variations, renewal and manufacturing site certificate application and maintenance.</li><li>
Ensure filing strategy is aligned with global strategy.</li><li>
Gather and share regulatory or safety intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders.</li><li>
Ensure maintenance of appropriate systems for Regulatory activities and documentation.</li><li>
Ensure regulatory budget is prepared and maintained and aligned with global budget requirements.</li><li>
Establish and implement plans to maintain a trusted relationship with local authorities through regular meeting and discussions where appropriate.</li><li>
Ensure validity of Scientific Office licenses based on Local HA regulations.</li><li>
Respond to authorities&rsquo; inquiries related to Scientific Office.</li></ul><div></div><div>
What you&rsquo;ll bring</div><ul><li>
Bachelor&rsquo;s degree or equivalent or higher, in Pharmacy</li><li>
Saudi National with a Pharmacist license from the Saudi Council of Health Specialities</li><li>
At least 5 years&rsquo; experience in regulatory affairs dealing with a wide variety of registration projects and issues.</li><li>
Experience in dealing with Pharmacovigilance matters.</li><li>
Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance.</li><li>
Ability to develop strategies and solutions within the regulatory and safety context within the scope of global requirements and available resources.</li><li>
Strong initiation and organization skills</li><li>
Outstanding written and oral communication and negotiation skills.</li><li>
Knowledge, experience and track record of delivering successful outcomes for regulatory, safety and TSO activities</li><li>
Good technical skills in the local HA online submission system or equivalent systems</li></ul><div></div><div>
What we offer in return</div><ul><li>
Opportunities for learning &amp; development through our varied programme</li><li>
Collaborative, inclusive work environment</li></ul><div></div><div>
Diversity and inclusion</div><div>
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn&rsquo;t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.</div><div></div><div>
About Mundipharma</div><div></div><div>
Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.</div><div>
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.</div><div></div><div>
Join our talent pool</div><div></div><div>
If you&rsquo;re not sure this role is right for you but you&rsquo;re keen to hear about future opportunities at Mundipharma, <div>join our talent community</div> and be the first to hear about new roles.</div><div></div><div><br>
Additional Job Description:</div><div></div><div>
Primary Location:</div>
SA Riyadh<div>
Job Posting Date:</div>
2025-08-13<div>
Job Type:</div>
Permanent</div>

Regulatory Affairs TSO Manager KSA

Takamol Holding

<div>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 We are seeking an experienced Public Policy Expert to support the design, development, and implementation of evidence-based public policy initiatives. The ideal candidate will play a critical role in shaping strategic policy recommendations, evaluating impact, advising on regulatory frameworks, and driving advocacy efforts to support effective policy implementation.
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Policy Design and Development
  </li>
  <li>
   Lead the development of evidence-based public policy proposals, strategies, and recommendations.
  </li>
  <li>
   Conduct in-depth policy analysis using qualitative and quantitative research methods.
  </li>
  <li>
   Synthesize complex information into actionable insights and structured deliverables.
  </li>
  <li>
   Evaluation and Monitoring
  </li>
  <li>
   Design and implement frameworks for ongoing evaluation, review, and monitoring of policy impact.
  </li>
  <li>
   Provide data-driven assessments of policy effectiveness and propose refinements.
  </li>
  <li>
   Develop KPIs and monitoring systems aligned with national and sectoral goals.
  </li>
  <li>
   Regulatory and Compliance Strategy
  </li>
  <li>
   Advise on regulatory frameworks and compliance requirements relevant to the policy area.
  </li>
  <li>
   Provide strategic guidance on aligning policy goals with legal and institutional structures.
  </li>
  <li>
   Identify regulatory gaps and propose practical, enforceable solutions.
  </li>
  <li>
   Research and Advocacy
  </li>
  <li>
   Conduct research to support evidence-informed advocacy efforts.
  </li>
  <li>
   Draft policy briefs, position papers, and stakeholder engagement strategies.
  </li>
  <li>
   Represent the organization in policy dialogues, working groups, and public forums.
  </li>
  <li>
   Policy Implementation Support
  </li>
  <li>
   Translate policy recommendations into actionable implementation plans.
  </li>
  <li>
   Work closely with internal and external stakeholders to ensure alignment and feasibility.
  </li>
  <li>
   Support the development of capacity-building initiatives related to policy rollout.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <strong>
  Job Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s or Master&rsquo;s degree in Public Policy, Economics, Political Science, Law, or a related field.
  </li>
  <li>
   10+ years of relevant experience in public policy, governance, or regulatory affairs.
  </li>
  <li>
   Demonstrated ability to lead and contribute to complex, multi-stakeholder policy projects.
  </li>
  <li>
   Strong analytical, writing, and presentation skills.
  </li>
  <li>
   Fluency in English [and Arabic if applicable].
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Familiarity with national policy frameworks and regional governance systems.
  </li>
  <li>
   Experience working with government entities, think tanks, or international organizations.
  </li>
  <li>
   Ability to translate policy theory into practical, on-the-ground application.
  </li>
 </ul>
</div>


Consulting Director

Zakat, Tax and Customs Authority

<div>
 <strong>
  Job Purpose
  <br/>
  <br/>
 </strong>
 BoD &amp; Committees Affairs Senior Specialist
 <br/>
 <br/>
 Jobholders at this level are capable of operating with minimal supervision. They work within guidelines and procedures in order to prepare more complex, specialized or ad-hoc reports in their related field. They contribute to the completion of milestones or operational targets within the assigned functional area.
 <br/>
 <br/>
 They undertake operational activities including following-up on processing of members&rsquo; remuneration and preparing necessary requests and replies.
 <br/>
 <br/>
 <strong>
  Roles And Responsibilities
  <br/>
  <br/>
 </strong>
 BoD &amp; Committees Set-Up
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Develop ZATCA&rsquo;s BoD and Committees&rsquo; related charters, policies, processes, templates and meeting protocols to regulate and standardize implementation of practices
  </li>
  <li>
   Coordinate with the relevant Committee to define the remuneration of the BoD and Committees&rsquo; members
  </li>
  <li>
   Follow-up for the completion of all members&rsquo; files including appointment letter, membership period, etc. and handle needed renewals
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 BoD &amp; Committees Affairs
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Follow-up with Accounting general department for timely processing of the BoD and Committees&rsquo; members&rsquo; remuneration
  </li>
  <li>
   Prepare requests and replies to the letters sent on behalf of the BoD and Committees under the supervision of the Chairman of BoD and Committees&rsquo; Chairmen
  </li>
  <li>
   Collect, assess and evaluate BoD and Committees&rsquo; members&rsquo; performance and develop reports highlighting issues and recommendations for improvement
  </li>
  <li>
   Coordinate program, logistics and protocols for BoD and Committees&rsquo; members&rsquo; business visits abroad and incoming VIP guests (visas, flights, accommodation, transportation, etc.)
  </li>
  <li>
   Prepare meeting minutes covering the main topics of discussion, deliberations, and decisions made
  </li>
  <li>
   Follow-up on the implementation of the decisions of the Governing Council and its committees and answer all relevant queries
  </li>
  <li>
   Support the Council and its committees in all matters relating to the work of the Commission in general and the Council and its committees in particular
  </li>
  <li>
   Advice the Council and its committees on the Council's governance
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 Organization and Operations
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Follow all relevant policies, processes and standard operating procedures so that work is carried out in a controlled and consistent manner
  </li>
  <li>
   Help in solving escalated problems and provide needed support for junior team to ensure work is carried out in an efficient manner
  </li>
  <li>
   Escalate complex problems to the relevant person to ensure cases/issues are closed properly
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Job Qualifications And Requirements
  <br/>
  <br/>
 </strong>
 A minimum of 2 years of relevant experience
 <br/>
 <br/>
 Bachelor&rsquo;s degree in Business Administration or equivalent is required
</div>


Committees Affairs & Governance Senior Specialist

Bank AlJazira | بنك الجزيرة

<div>
 <ul>
  <li>
   Ensure understanding of the strategic objective for the Bank and support in achieving the department's strategy and related strategic plans.
  </li>
  <li>
   Work closely with the CG Division Leadership / Governance committee, plus all Governance consultants, advisors, etc., to support BoD and Senior Management Governance initiatives.
  </li>
  <li>
   Follow up on Business area compliance with all mandated Corporate Governance issues and directives in a timely and effective manner, and report any noted deficiencies up the chain of command, as appropriate.
  </li>
  <li>
   Provide consultative and advisory services to all levels of BAJ management, as applicable and required.
  </li>
  <li>
   Utilize all available external tools and intelligent analysis to assist in the development of governance decision frameworks;
  </li>
  <li>
   Maintain fluid, regular, consistent and positive contact and communication with the regulators and other oversight agencies through the appropriate communication channels;
  </li>
  <li>
   Assure BoD &amp; Bank Compliance management awareness of all incoming CG regulatory directives and initiatives.
  </li>
  <li>
   Supports the development and implementation of international best practices in Corporate Governance across Bank Al Jazira, including interactions with its subsidiary entities;
  </li>
  <li>
   Works with the Head of Corporate Governance to define the required corporate governance standards for Bank Al Jazira based on emerging best practices and regulatory requirements;
  </li>
  <li>
   Manages the updates to the Bank Al Jazira Corporate Governance manual, Delegations of Authorities matrix and Conflict of Interest Registry
  </li>
  <li>
   Reviews and manages updates to all Corporate Governance manuals, related policies and procedures
  </li>
  <li>
   Assists in the Supervision of Corporate Governance practices across the Bank, and raises concerns and gaps identified up the chain of Command, as required;
  </li>
  <li>
   Assists CG Management in the review and supervision of Corporate Governance practices across the Bank and in the preparation of a report on identified concerns and gaps, for Board and Board Committee Presentation
  </li>
  <li>
   Assists in the dissemination of corporate governance related communication with external parties including publication of corporate governance activities in the Annual Report and other external communications (e.g., press releases)
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  Requirement:
 </p>
 <ul>
  <li>
   Bachelor's Degree in Law, Business Administration or any relevant major.
  </li>
  <li>
   Around 5 years of experience with a preference 3 years of experience in a relevant role.
  </li>
  <li>
   Prior experience in Regulatory Banking Practices, or Oversight Reporting and Monitoring.
  </li>
 </ul>
</div>


Corporate Governance Manager

PROVEN Arabia | بروفن العربية

<div>
 Job Title: Government Affairs Manager (Saudi National)
 <br/>
 <br/>
 Location: Saudi Arabia
 <br/>
 <br/>
 <strong>
  Job Purpose
  <br/>
  <br/>
 </strong>
 The Government Affairs Manager will be responsible for developing and maintaining strong relationships with government entities, regulatory bodies, and key stakeholders in Saudi Arabia. The role ensures compliance with local laws and regulations, supports the company&rsquo;s strategic objectives, and advocates for the company&rsquo;s interests in alignment with Saudi Vision 2030.
 <br/>
 <br/>
 <strong>
  Compensation &amp; Benefits
  <br/>
  <br/>
 </strong>
 Key Responsibilities
 <br/>
 <br/>
 <ul>
  <li>
   Act as the primary point of contact with all regulatory bodies in KSA and other relevant jurisdictions, ensuring timely, accurate, and legally sound responses to inquiries and requirements.
  </li>
  <li>
   Oversee all licensing, permit issuance, renewals, and related government processes for the organization, ensuring compliance with applicable laws and regulations.
  </li>
  <li>
   Monitor and interpret government policies, regulations, and emerging regulatory bodies; ensure their integration within the Legal function and company operations.
  </li>
  <li>
   Develop and maintain the Regulatory Affairs Policy to reflect current legal obligations, compliance standards, and operational practices.
  </li>
  <li>
   Collaborate with Corporate Planning, Legal, and other business units to support licensing, regulatory filings, and approvals for existing and new services.
  </li>
  <li>
   Represent the company in government meetings, committees, and industry associations while building and maintaining strong networks with ministries, authorities, and key stakeholders.
  </li>
  <li>
   Support management in resolving regulatory issues, preparing reports and policy briefs, and advising leadership on regulatory changes and emerging trends.
  </li>
  <li>
   Drive engagement with CITC and other regulators, ensuring effective coordination across teams to align regulatory, legal, and operational objectives.
  </li>
  <li>
   Ensure compliance with Saudi labor, commercial, and regulatory requirements while supporting Saudization and CSR initiatives in line with national goals.
  </li>
  <li>
   Maintain strong working knowledge of all key Saudi government platforms (e.g., Qiwa, GOSI, Muqeem, Mudad, Balady, etc.) and ensure their effective use in company operations.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications &amp; Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in Public Administration, Political Science, Law, Business Administration, or a related field (Master&rsquo;s preferred).
  </li>
  <li>
   Minimum of 7&ndash;10 years of experience in government relations, regulatory affairs, or public affairs, preferably in Saudi Arabia.
  </li>
  <li>
   Strong understanding of Saudi government structure, regulations, and Vision 2030 initiatives.
  </li>
  <li>
   Experience in regulatory filings, compliance processes, and government licensing.
  </li>
  <li>
   Excellent networking, communication, and negotiation skills
  </li>
  <li>
  </li>
  <li>
   Proven track record of managing regulatory issues and government relations.
  </li>
  <li>
   Fluency in Arabic and English (spoken and written).
  </li>
  <li>
   Saudi nationals preferred (as per local market practice).
  </li>
 </ul>
</div>


Government Affairs Manager

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