manager of regulatory affairs

Rawaj - Human Capital Management

<div><p>Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.</p><p>
The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.</p><h3 class="jobSectionHeader"><b>
Key Accountabilities</b></h3><ul><li><p>
Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.</p></li><li><p>
Manage communication with SFDA authorities for product approvals and renewals.</p></li><li><p>
Track and interpret new regulations impacting medical device compliance.</p></li><li><p>
Maintain product registration database and ensure documentation accuracy.</p></li><li><p>
Collaborate with QA, R&amp;D, and Production to ensure regulatory alignment.</p></li></ul><h3 class="jobSectionHeader"><b>
Knowledge, Skills, and Experience</b></h3><ul><li><p>
Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, or Science.</p></li><li><p>
8+ years of experience in Regulatory Affairs for medical devices.</p></li><li><p>
Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.</p></li><li><p>
Strong documentation and submission management skills.</p></li><li><p>
Excellent English communication.</p></li></ul></div>

Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia

Danone

<div>About the job
<p><b>
Danone T&uuml;rkiye</b> is looking for a talented colleague for the <b>&quot;Regulatory Affairs Manager </b>&quot; position. Take this opportunity to GROW together!</p><br>
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As a Regulatory Affairs Manager, you will be an <i>individual contributor</i> in this role and reporting to the <i>Head of Regulatory Affairs.</i></p><br>
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In this role you will;</i></b><i>
 </i></p><p><i>Ensure sufficient compliance governance to meet regulatory obligations of the dairy business unit
</i></p><ul><li><i>Ensure full compliance of recipes, products, labeling and any kind of product communication (press, TV, online, etc.)
</i></li></ul><ul><li><i>Provide regulatory assessments for innovation projects to give direction by exploiting opportunities where possible and avoiding regulatory hurdles
</i></li></ul><ul><li><i>Lead and manage product approval and licensing process related to products
</i></li></ul><ul><li><i>Propose &amp; implement action plans in response to regulatory changes in the market</i></li></ul>
<ul><li><i>Anticipate the development of new regulations and effectively communicate company position in relevant external environment
</i></li></ul><ul><li><i>Advocacy and lobby on new regulation development via trade associations and by establishing effective relationship with authorities
</i></li></ul><p><i>&bull; Educate all relevant functions on regulatory compliance to ensure consistent implementation of regulatory requirements &bull; Identify and predict issues that could impact the business and communicate them to relevant business partners; assist them to implement agreed actions
</i></p>About you
<ul><li>Have at least 5 years of related experience in Food, Beverage sector in Regulatory Affairs department</li></ul>
<ul><li>University degree in Food Engineer, Chemical Engineer, or relevant disciplines</li></ul>
<ul><li>Have in knowledge of food and beverages&rsquo; regulations and related EU regulations (preferably)</li></ul>
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&bull; Excellent command of written and spoken English &bull; Attention to details, very-well organized, and logical/systematic thinking</p>
<ul><li>Capable to pro-actively engage and liaise with internal/external stakeholders (good communication skills)</li></ul>
About us
<p><b>
Being a Danoner means that you create your own working experience.</b></p><br>
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<li>You could design your own way of working with our hybrid working model.</li>
<li>Our head office is in Ata&#351;ehir.</li>
<li>You could decide your daily 8-hours of working period within our flexible-working hours practice.</li>
<li>We know that you will have home expenses during home office days. So, Danone supports you for your expenses with an allowance as well!</li>
<li>Summers are flexible here! You could work fully remote for 4 weeks during July and August.</li>
<li>We also enjoy Fridays during summer period between July and August by finishing our works by 1500 and enjoy the rest of the day and starting the weekend earlier.</li>
Danone offers various types of leave days to support Danoners&rsquo; work-life balance and well-being. We have a wide variety of leave types, such as in your first year 5 days of &quot;Im New in Danone Leave&quot;; 1 day of &quot;My Future is Good Leave&quot; for our social responsibility activities. These options cater to different aspects of employees' lives and needs, reflecting the company's commitment to not only professional growth but also personal and social responsibilities.<br>
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</li></ul><p>We are proud to promote diversity and equal opportunity within our teams. We believe that our differences will make a difference, and that an inclusive work environment will drive our growth as a company, as a team, and as individuals. We will therefore consider all implementations* by fostering an inclusive work culture where everyone can feel at home.<br>
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All nominations will be considered regardless of origin, background, religion, sex, sexual orientation, age, gender identity, disability.<br>
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<b>Working with us</b> is about being able to do things your way. The way you work, the way you develop, the way you progress,<b> i</b><b>t&rsquo;s all up to you.</b><br>
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Working here, you&rsquo;ll need to enjoy a fast-paced environment, a little complexity and challenging tasks but it is packed with opportunities. You will work for some of the best-known brands in the world, such as Activia, Danone, Danino, Danette, Aptamil, Bebelac, Hayat, and S&#305;rma, and we absolutely guarantee that you can just be yourself.<br>
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<b>Be innovative and entrepreneurial and the impact you could make might just amaze you</b>. Join our movement for a healthier world. <b>One Planet One Health BY YOU.</b><br>
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At Danone T&uuml;rkiye, inspired by our <b>B Corp</b> journey, we continuously challenge ourselves to improve and measure our social and environmental impact. This journey inspires us to constantly challenge ourselves, measure what truly matters, and create long-term value &mdash; not just for our business, but for our people, partners, communities, and future generations. <b>If you&rsquo;re looking to grow your career with purpose, you&rsquo;re in the right place.</b></p><br>
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What&rsquo;s next?</b><br>
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Visit our website www.danone.com to discover more about us and to find out how you could be part of it all!</p></div>

Regulatory Affairs Manager (Temporary)

Allmed Solutions

<p><b>Job description</b></p><p>We are seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team. The Senior Officer &ndash; Regulatory Affairs will be responsible for overseeing all 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 for product approvals.</li><li>Manage product registration and documentation processes.</li><li>Ensure compliance with regulatory requirements .</li><li>Coordinate and communicate with regulatory agencies for submissions and approvals.</li><li>Maintain ongoing regulatory compliance throughout the product lifecycle.</li><li>Support cross-functional teams with regulatory insights and updates.</li></ul><p><b>Requirements:</b></p><ul><li>Master&rsquo;s degree (MSc.) in a relevant field.</li><li><b>1&ndash;2 years of experience</b> in regulatory affairs, preferably in medical devices.</li><li>Excellent communication, documentation, and analytical skills.</li><li>Proven ability to multitask, prioritize, and meet strict deadlines in a fast-paced environment.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs50,000.00 - Rs120,000.00 per month</p><p>Work Location: In person</p>

Senior Officer – Regulatory Affairs

Human Capital HR Solutions

<p>The <b>Assistant Manager &ndash; Regulatory &amp; Corporate Affairs</b> will ensure full compliance with all statutory and regulatory requirements while supporting the company&rsquo;s legal, licensing, and corporate governance activities. The role requires close coordination with internal departments, legal counsel, and government authorities to maintain a compliant and well-governed business environment.</p><p><b>Key Responsibilities:</b></p><ul><li>Ensure compliance with <b>local laws, regulatory bodies, and industry standards.</b></li><li>Manage <b>regulatory filings, licenses, renewals, and statutory documentation.</b></li><li>Liaise with <b>government departments, legal advisors, and industry associations.</b></li><li>Support <b>corporate documentation</b>, board meetings, and policy development.</li><li>Prepare and review <b>contracts, agreements, and legal correspondences.</b></li><li>Facilitate <b>internal and external audits</b> conducted by regulatory authorities.</li><li>Monitor and report on <b>new or updated regulations</b> affecting company operations.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs120,000.00 - Rs170,000.00 per month</p><p>Work Location: In person</p>

Assistant Manager – Regulatory & Corporate Affairs

Viatris

<div>Viatris &#304;la&ccedil;lar&#305; Ltd. &#350;ti<div></div><div>
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.<br>
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Viatris empowers people worldwide to live healthier at every stage of life.<br>
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We do so via:<br>
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Access &ndash; Providing high quality trusted medicines regardless of geography or circumstance;<br>
Leadership &ndash; Advancing sustainable operations and innovative solutions to improve patient health; and<br>
Partnership &ndash; Leveraging our collective expertise to connect people to products and services.</div><div><br>
Every day, we rise to the challenge to make a difference, and here&rsquo;s how the Regulatory Relations Manager (Ankara) role will make an impact:</div><div></div><div>
The objective of this job is to be the single point of contact for Viatris Regulatory Affairs and Health Authority (HA) relations.</div><div></div><div>
Key responsibilities for this role include:</div><ul><li><div>
Interactions with Health Authority for regulatory submissions, approvals, follow-up submissions, quality compliance and all Istanbul manufacturing site related regulatory activities, out of stock communications, importation, sample analysis, GMP, face to face related discussions.</div></li><li><div>
Follows-up of all regulatory submissions/correspondences with Health Authority and notifies regulatory team in a timely manner.</div></li><li><div>
Follows-up sample analysis related to regulatory submissions.</div></li><li><div>
Reports pending regulatory approvals on a regular basis to ensure that all related Health Authority requests are attended.</div></li><li><div>
Ensures that all regulatory files are correctly maintained and secured as determined in procedures.</div></li><li><div>
Follows-up on local system updates, makes regulatory submission, queries and approval announcements and run regulatory systems reports.</div></li><li><div>
Residency in Ankara is required.</div></li></ul><div></div><div>
The minimum qualifications for this role are:</div><ul><li>
 University degree.</li><li>
 More than 5 years of experience in the same position.</li><li>
 Advanced Turkish and English in writing and speaking.</li><li>
 Male candidates must have completed their military service.</li><li>
 Ability to use Microsoft Office programs effectively.</li></ul><div></div><div>
At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.</div><div></div><div>
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.</div><div></div><div>
Viatris is an Equal Opportunity Employer.</div></div><div></div>

Regulatory Relations Manager (Ankara)

Talent House Co.

<p><b>About the Role</b></p><p>We are seeking a <b>Governance and Corporate Affairs Manager</b> to develop, implement, and oversee governance frameworks across the Group and its subsidiaries. This role ensures full compliance with legal and regulatory requirements, strengthens corporate accountability, and supports transparent decision-making to build trust among stakeholders in a complex, multi-business environment.</p><p><b>Key Responsibilities</b></p><p><b>Governance Framework (50%)</b></p><ul><li>Lead the review, development, and implementation of the Group&rsquo;s corporate governance framework.</li><li>Advise subsidiaries on governance and corporate affairs matters under the guidance of the Group Chief Legal Officer (GCLO).</li><li>Draft, update, and maintain governance policies, delegation of authority, and related procedures.</li></ul><p><b>Compliance &amp; Risk Oversight (10%)</b></p><ul><li>Ensure compliance with applicable laws, regulations, and industry standards.</li><li>Monitor emerging regulatory requirements and recommend enhancements.</li><li>Identify, assess, and mitigate governance-related risks.</li></ul><p><b>Reporting &amp; Documentation (20%)</b></p><ul><li>Prepare and present governance reports to executive leadership and the Board.</li><li>Maintain corporate records, statutory registers, and minute books.</li><li>Ensure accurate and timely filing of statutory and regulatory documents.</li></ul><p><b>Stakeholder Engagement (10%)</b></p><ul><li>Liaise with internal departments to coordinate governance and compliance requirements.</li><li>Engage with external auditors, regulators, and industry associations.</li><li>Support Board and executive leadership with governance-related matters.</li></ul><p><b>Training &amp; Support (10%)</b></p><ul><li>Facilitate internal and external audits related to governance and compliance.</li><li>Deliver guidance and awareness sessions on governance best practices across subsidiaries.</li><li>Stay updated on emerging governance trends.</li></ul><p><b>Who You&rsquo;ll Work With</b></p><p><b>Internal:</b> Board of Directors, Compliance &amp; Risk Management Team, Department Heads<br/><b>External:</b> Regulatory Authorities, External Auditors, Industry Associations</p><p><b>Working Conditions</b></p><ul><li><b>Environment:</b> Office-based</li><li><b>Risk Level:</b> Low</li><li><b>Remote Work:</b> Not permitted</li></ul><p><b>Qualifications</b></p><p><b>Education &amp; Certification</b></p><ul><li>Bachelor&rsquo;s degree in Law, Business Administration, Corporate Governance, or a related field.</li><li>Master&rsquo;s degree or professional certification (ICSA, CPA, CIA) preferred.</li></ul><p><b>Experience</b></p><ul><li>5&ndash;10 years of experience in governance and corporate affairs, ideally within Saudi Arabia or the Middle East.</li><li>Background in construction, real estate, or other regulated industries is an advantage.</li></ul><p><b>Skills</b></p><ul><li>Strong understanding of corporate governance frameworks and board operations.</li><li>Proficiency in governance management systems, board portals, and record-keeping tools.</li><li>Excellent research, analytical, and problem-solving abilities.</li><li>Strong communication and interpersonal skills in <b>Arabic and English</b>.</li><li>Proven ability to manage multiple stakeholders and deadlines in a diversified group structure.</li></ul><p><b>Additional Information</b></p><ul><li>This is a <b>managerial role</b>, not administrative or clerical.</li><li><b>Bilingual (Arabic &amp; English)</b> proficiency is required.</li><li><b>Preference will be given to Saudi nationals.</b></li></ul><p>Job Type: Full-time</p><p>Pay: &#65020;45,000.00 - &#65020;50,000.00 per month</p><p>Education:</p><ul><li>Master's (Preferred)</li></ul>

Manager – Governance and Corporate Affairs (Saudi)

Novartis Farmacéutica

Choose LocationChoose Location# Global Regulatory Affairs Associate Director (Cardio-Metabolic)REQ-Oct 14, 2025United Kingdom  Summary (12 days per month on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Associate Director We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team.The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle.  About the Role Major accountabilities: Lead the implementation of regulatory strategies and operational activities across major global regions. Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents. Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams. Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials. Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans). Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize review delays and regulatory clock stops. Ensure timely and compliant responses to HA queries and requests. Contribute to departmental goal setting and lead initiatives to improve regulatory processes. Ensure adherence to internal policies, SOPs, and global regulatory requirements. Minimum requirements: Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Significant experience in regulatory affairs within the pharmaceutical industry. Proven track record in project management and regulatory operations. Experience representing the organization in cross-functional and cross-cultural settings. Strong knowledge of clinical trials, drug development, and regulatory compliance. Excellent problem-solving, negotiation, and communication skills. Detail-oriented with the ability to manage complex regulatory projects. Skilled in risk management and working with cross-functional teams. Ability to navigate and influence Health Authority interactions. Fluency in English (written and spoken) is essential. Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Join our Novartis Network: Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:DevelopmentUniversal Hierarchy NodeUnited KingdomLondon (The Westworks)GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.Research & DevelopmentFull timeRegularNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.REQ-  Global Regulatory Affairs Associate Director (Cardio-Metabolic)<img src="https://www.jobg8.com/Tracking.aspx?n70Gs5vBCd8IWwUuLMXZlaNb9isvX8%2f5f" width="0" height="0" />

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

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