regulatory affairs director

Qiddiya | القدية

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  Qiddiya is Saudi Arabia's future capital of entertainment, sports, and culture &mdash; a 360 km&sup2; mega-project just outside Riyadh. From F1-grade racetracks and theme parks to stadiums and performance venues, we're creating a destination like no other. This is more than a project, it's a national transformation. As construction accelerates, we're hiring ambitious talent to help shape it. If you're driven by scale, impact, and the chance to build something iconic from the ground up, Qiddiya is calling for you.
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  General Summary:
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 The Director of Regulatory and Policy is a strategic leadership role within the Transport Division, responsible for shaping and influencing the regulatory and policy environment in which the organization operates. This role requires a forward-thinking leader who can monitor emerging trends, assess comparative regulatory settings, and advocate for policy reform that enables innovation in the transport sector.
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 The successful candidate will bring extensive experience in regulatory policy within the Middle East&mdash;particularly Saudi Arabia&mdash;and possess a strong inter-governmental network that can be leveraged to align regulatory frameworks with strategic transport initiatives.
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 The role also plays a vital part in talent development, fostering a high-performing and collaborative team environment in a fast-paced, evolving ecosystem.
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  Essential Duties and Responsibilities:
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   Lead the development and refinement of regulatory and policy positions that support the Transport Division's strategic and operational goals
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   Conduct comparative analysis of local, regional, and international regulatory frameworks to identify policy gaps, best practices, and opportunities for alignment or reform
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   Scan the regulatory and innovation landscape for emerging technologies, business models, or trends requiring proactive policy response (e.g., autonomous transport, mobility-as-a-service, decarbonization)
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   Serve as a key liaison with government entities, regulators, and policy-makers, leveraging a deep network to advocate for and influence policy evolution
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   Prepare regulatory strategy papers, submissions, and briefings for executive leadership and external stakeholders
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   Coordinate cross-functional regulatory initiatives, collaborating with Legal, Strategy, Projects, and Government Affairs to ensure coherent messaging and outcomes
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   Develop internal policy positions that support compliance, strategic innovation, and operational flexibility
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   Build and maintain trusted relationships with key decision-makers across Saudi ministries, regulatory bodies, and policy think tanks
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   Support internal and external lobbying efforts through data-driven analysis, policy articulation, and stakeholder engagement
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   Create a strong team culture, mentor junior staff, and foster professional development in a dynamic, mission-driven environment
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  Requirements
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  Qualifications:
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   Bachelor's degree in Public Policy, Law, Political Science, Transport Planning, or related discipline
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   Master's degree in Public Administration, Transport Policy, or Regulatory Affairs preferred
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   Strong understanding of the transport regulatory environment in Saudi Arabia and broader Middle East
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   Deep knowledge of transport policy trends, including urban mobility, innovation regulation, infrastructure standards, and market reform
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   Exceptional communication, writing, and negotiation skills, with the ability to present regulatory arguments clearly and persuasively to diverse audiences
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   Demonstrated ability to work under pressure, manage competing priorities, and deliver results in fast-moving policy environments
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  Years of Experience:
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 Minimum 15+ years of experience in regulatory, legal, or public policy roles, with at least 5 years focused on transport-related regulation.
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  Experience:
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   Significant experience in the Middle East, with deep working knowledge of Saudi Arabia's institutional and regulatory landscape
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   Proven track record in regulatory design, reform advocacy, and policy analysis at the national or intergovernmental level
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   Strong experience engaging and influencing government entities and regulatory bodies on complex transport or infrastructure issues
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   Experience building and leading high-performing policy teams, with a focus on mentoring and team culture
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   Demonstrated ability to operate efficiently and pragmatically within complex, rapidly evolving organizational and policy ecosystems
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Director - Regulatory and Policy (CDU3) - 20002659

Protectol Health

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  Job Summary:
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  We are seeking an experienced and detail-oriented Regulatory Affairs Officer to join our team in Oman. The ideal candidate will be responsible for managing regulatory submissions, ensuring product compliance with local health authority regulations, and maintaining up-to-date knowledge of evolving regulatory requirements, particularly with the Oman Ministry of Health (MOH).
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    Key Responsibilities:
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   Prepare, compile, and submit product registration dossiers to the Oman Ministry of Health and other relevant regulatory bodies.
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   Maintain current knowledge of regulations, guidelines, and standards relevant to pharmaceutical, medical device, or healthcare product registration in Oman.
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   Ensure timely renewals, variations, and updates of licenses and product registrations.
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   Liaise with internal departments (Quality, Manufacturing, R&amp;D) to gather technical documents and support regulatory submissions.
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   Communicate and coordinate with regulatory authorities to ensure smooth submission processes and resolve any queries.
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   Monitor post-market regulatory requirements, including adverse event reporting, labeling compliance, and batch notification.
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   Track and maintain accurate records of all regulatory activities and ensure compliance documentation is up to date.
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   Support internal and external audits and inspections.
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  Requirements:
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   Bachelor's degree in pharmacy, Life Sciences, or a related field (master&rsquo;s preferred).
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   Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical, medical device, or healthcare sector.
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   Strong knowledge of Oman MOH regulations and submission processes.
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   Oman MOH License preferred.
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   Excellent written and verbal communication skills in English (Arabic is an advantage).
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   Strong organizational skills, attention to detail, and the ability to manage multiple projects.
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   Proficient in MS Office applications and regulatory databases.
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Regulatory Affairs Executive

Mondelēz International

<p></p><div><div><p>Job Description</p><p></p><p><b>
Are You Ready to Make It Happen at Mondelēz International?</b></p><p></p><p><b>
Join our Mission to Lead the Future of Snacking. Make It With Pride.</b></p><p></p><p>
You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies, regulatory programs and requirements of our portfolio carried out.</p><p></p><p><b>
How you will contribute</b></p><p></p><p>
You will deliver on the regulatory affairs strategy and compliance agenda and work with cross-functional stakeholders to assess regulatory business risks and opportunities. You will provide regulatory affairs expertise for technical regulatory developments and help in responses to challenges and crisis management. In this role, you will ensure that ingredients, product composition, claims and labelling compliance are within applicable regulations and company policies. In addition, you will provide guidance to stakeholders on developments in regulatory affairs, support regulatory impact assessments and change management, help develop regulatory affairs tools, and further develop your knowledge of regulatory, science and nutrition risks and opportunities in your market.</p><p></p><p><b>
What you will bring</b></p><p></p><p>
A desire to drive your future and purpose, accelerate your career and the following experience and knowledge:</p><ul><li>
Networking and communication skills</li><li>
Reliability and accuracy and an efficient work style</li><li>
Meeting deadlines</li><li>
Attending to detail</li><li>
Project management</li><li>
Regulatory affairs in an international and multi-functional environment</li></ul><p></p><p><b>
More about this role</b></p><p>
This position will be responsible for executing the regulatory affairs strategy for their respective categories and geographical area using their technical and regulatory knowledge ensuring compliance to our policies, regulatory programs and requirements of our portfolio.</p><p></p><p><b>
What you need to know about this position:</b></p><ul><li>
This position is a regional position that reports to the Regulatory Center and located at Thane, India. The candidate will be responsible for regulatory affairs for AMEA markets (within Regulatory Centre) and perform daily regulatory activities assigned to the internal hub. This position requires ensuring all projects and Regulatory activities assigned to the internal hub are delivered efficiently, in a timely manner, and are fully compliant with applicable regulations.</li><li>
Manage multiple regulatory project activities for the corresponding region and all categories where required</li><li>
Identifies and escalates risks and issues in regular governance meetings and drives resolution as needed</li><li>
Take personal responsibility for personal growth, driving team collaboration, and finding new, improved, and simpler ways to work.</li><li>
Collaborate and drive various processes and functions within RDQ to include Process/Product/Package Development, Research, Quality, Regulatory &amp; scientific affairs.</li></ul><p></p><p><b>
Education / Certifications:</b></p><p>
Bachelor&rsquo;s or equivalent in relevant field (Food Science or Nutrition preferred)</p><p></p><p><b>
Job specific requirements:</b></p><ul><li>
3- 5 years of experience in Regulatory or related field at a global food manufacturer.</li><li>
Strong attention to detail with a passion to advance regulatory compliance technical skills</li><li>
Basic to Intermediate knowledge in SAP-PLM especially in troubleshooting Issues.</li><li>
Basic knowledge to Digital Regulatory tools (Dragonfly Artwork Approval System, DECERNIS, etc.) including simple troubleshooting of system issues.</li><li>
Technology savvy and willing to work with new system testing and transferring knowledge and experience into SOPs, Job Aids and tool sheets.</li><li>
Basic knowledge of the national Food law regulations for countries of responsibility as well as International Standards (e.g. Codex, FSANZ, GCC) is preferred.</li><li>
Good knowledge of Mondelez business, i.e. market environment and Mondelez trade position as well as Mondelez manufacturing processes and portfolio.</li></ul><p></p><p><b>
Travel requirements:</b></p><p>
Very minimum (max once a year)</p><p></p><p><b>
Work schedule:</b></p><p>
Full-Time</p><p></p>
No Relocation support available<p></p><p>
Business Unit Summary</p><p></p><div>
Mondelēz International in the Middle East, North Africa and Pakistan serves the Middle East and Africa markets as well as Australia, New Zealand, the UK and Canada. Headquartered in Dubai, UAE, we have more than 2600 employees working across seven plants and six commercial offices; we make, bake, sell and deliver our products to customers. We are market leaders in key snacking categories with iconic global and local brands including Cadbury Dairy Milk chocolate, Milka, Oreo and belVita biscuits, Barni Cakes,Tang powdered beverage, Chiclets and Trident gum and Halls candy.</div><p></p><p>
Mondelēz International is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.</p><p></p><p>
Job Type</p><p></p>
Regular<p></p>
Scientific Affairs &amp; Regulatory Affairs<p></p>
Product Quality, Safety and Compliance</div></div><p></p>

Regulatory Specialist, SARA

<div>
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  Qiddiya is Saudi Arabia's future capital of entertainment, sports, and culture &mdash; a 360 km&sup2; mega-project just outside Riyadh. From F1-grade racetracks and theme parks to stadiums and performance venues, we're creating a destination like no other. This is more than a project, it's a national transformation. As construction accelerates, we're hiring ambitious talent to help shape it. If you're driven by scale, impact, and the chance to build something iconic from the ground up, Qiddiya is calling for you.
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  General Summary:
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 The Regulatory &amp; Policy team within the Transport Business Unit (TBU) plays a vital role in shaping the transport agenda at Qiddiya by ensuring alignment with national regulatory frameworks, policy environments, and sector-specific mandates. The team leads on regulatory submissions, inter-governmental engagement, policy impact assessments, and supports the TBU's compliance with external approvals and governance protocols. Working cross-functionally, the team serves as the BU's interface with external regulators, government bodies, and internal delivery stakeholders.
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 The Senior Manager supports the execution of the TBU's regulatory roadmap, manages key relationships with government agencies, and leads the preparation of critical regulatory submissions and position papers. The role ensures that regulatory timelines are met and that Qiddiya's interests are well-represented in external engagements.
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  Essential Duties and Responsibilities:
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   Support the Associate Director in managing approvals and permits from regulatory authorities
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   Coordinate development of regulatory documents and responses to government inquiries
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   Track and report on regulatory changes impacting transport projects
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   Build working relationships with government officials and regulatory entities
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   Support internal project teams with regulatory guidance and interface planning
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  Requirements
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  Qualifications:
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   Bachelor's degree in Public Policy, Law, Political Science, Transport Planning, or related discipline
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  Years of Experience:
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   8+ years in regulatory affairs, permitting, or policy advisory in a transport or infrastructure setting
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Senior Manager - Regulatory and Policy (CDU3) - CDUP 2064

Allmed Solutions

<p>We are seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team. The Assistant Manager &ndash; Regulatory Affairs will play a key role in managing regulatory activities related to medical devices, ensuring full compliance with local and international regulatory standards.</p><p><b>Key Responsibilities:</b></p><ul><li>Develop and implement effective regulatory strategies to support product approvals.</li><li>Manage product registration processes and prepare regulatory documentation.</li><li>Ensure compliance with applicable regulatory requirements and standards.</li><li>Liaise with regulatory authorities for submissions, queries, and approvals.</li><li>Maintain regulatory compliance throughout the entire product lifecycle.</li><li>Provide regulatory guidance and updates to cross-functional teams.</li></ul><p><b>Requirements:</b></p><ul><li><b>Doctor of Pharmacy (Pharm-D)</b> degree.</li><li><b>1&ndash;3 years</b> of experience in Regulatory Affairs, preferably within the <b>medical devices industry</b>.</li><li>Strong communication, documentation, and analytical skills.</li><li>Ability to multitask, prioritize workloads, and meet tight deadlines in a fast-paced environment.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs60,000.00 - Rs150,000.00 per month</p><p>Work Location: In person</p>

Assistant Manager – Regulatory Affairs

PROVEN

Overview <p>Job Title: Government Affairs Manager</p><p>Job Purpose: 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's strategic objectives, and advocates for the company's interests in alignment with Saudi Vision 2030.</p> Key Responsibilities <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.</li></ul> Qualifications & Requirements <ul><li>Bachelor's degree in Public Administration, Political Science, Law, Business Administration, or a related field (Master's preferred).</li><li>Minimum of 7-10 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>Proven track record of managing regulatory issues and government relations.</li><li>Fluency in Arabic and English (spoken and written).</li></ul> Seniority level <ul><li>Executive</li></ul> Employment type <ul><li>Full-time</li></ul> Job function <ul><li>Legal</li></ul> Industries <ul><li>Business Consulting and Services and Education</li></ul>

Government Affairs Manager (Education Industry)

India Health Link Pvt. Ltd.

<div><h3 class="jobSectionHeader"><b>Role Overview</b></h3><div>
India Health Link Private Limited is seeking a Regulatory Affairs &amp; Compliance Executive to support Indian and international regulatory activities for medical devices and healthcare products. The role will focus on CDSCO submissions, export regulatory coordination, early-stage US FDA strategy support, quality system documentation, and regulatory compliance across the product lifecycle.</div><div>
This position is ideal for a hands-on regulatory professional who is comfortable working across teams, managing documentation, and coordinating with external consultants and regulators.</div><div></div><h2 class="jobSectionHeader"><b><br>
Key Responsibilities</b></h2><h3 class="jobSectionHeader"><b>
Indian Regulatory Affairs (CDSCO)</b></h3><div>
Prepare, submit, and track CDSCO applications including Test Licenses, Manufacturing Licenses, and Free Sale Certificates (FSCs) through NSWS and SUGAM portals.</div><div>
Coordinate clinical study, testing, and evaluation requirements associated with regulatory submissions, working with clinical sites, CROs, manufacturing teams, and internal stakeholders.</div><div>
Track application status, respond to regulatory queries, and support timely approvals.</div><h3 class="jobSectionHeader"><b>
International Regulatory Affairs (Export Markets)</b></h3><div>
Support regulatory pathways for international/export markets in coordination with third-party regulatory agencies and consultants.</div><div>
Track country-specific regulatory dependencies, documentation requirements, and submission timelines.</div><div>
Maintain readiness and version control of documentation required for international regulatory submissions and renewals.</div><h3 class="jobSectionHeader"><b>
US FDA Regulatory Support</b></h3><div>
Support development and execution of a phased US FDA market-entry strategy, including identification of 510(k)-exempt product capabilities.</div><div>
Coordinate with CROs and regulatory consultants to assess FDA regulatory pathways, timelines, and scope of work.</div><div>
Assist in preparing for FDA Quality System and factory-readiness expectations as product scope and risk classification expand.</div><h3 class="jobSectionHeader"><b>
Quality System &amp; Compliance</b></h3><div>
Work closely with Quality Assurance teams to maintain ISO-compliant documentation, including Product Master Files (PMF), Quality Manual, regulatory SOPs, and technical documentation.</div><div>
Draft, review, and maintain regulatory reporting, vigilance, and post-market surveillance (PMS) documentation.</div><div>
Support internal and external audits related to regulatory, quality, and compliance requirements.</div><h3 class="jobSectionHeader"><b>
Data Privacy &amp; Other Regulatory Compliance</b></h3><div>
Coordinate implementation of data-privacy and data-compliance initiatives (including DPDPA requirements) in collaboration with internal teams and external vendors.</div><div>
Support compliance with applicable pricing, data protection, and regulatory frameworks (e.g., NPPA, DPDPA, where applicable).</div><h3 class="jobSectionHeader"><b>
Regulatory Strategy &amp; Documentation Management</b></h3><div>
Maintain device capability matrices, product classification mappings, and intended-use documentation across markets.</div><div>
Interpret regulatory requirements (CDSCO, US FDA, ISO, NPPA, DPDPA) and identify documentation gaps and mitigation actions.</div><div>
Act as a regulatory coordination point between manufacturing, QA, clinical partners, consultants, and management.</div><div></div><h2 class="jobSectionHeader"><b><br>
Qualifications &amp; Experience</b></h2><div>
Bachelor&rsquo;s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or a related discipline.</div><div>
2&ndash;5 years of experience in regulatory affairs, quality, or compliance within the medical device / healthcare / life sciences sector.</div><div>
Hands-on experience with CDSCO submissions and familiarity with NSWS/SUGAM portals.</div><div>
Working knowledge of ISO 13485, basic FDA regulatory concepts, and international regulatory frameworks.</div><div>
Strong documentation, coordination, and communication skills.</div></div><div></div>

Regulatory Affairs & Compliance Executive

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