regulatory affairs manager

HUMAN KAPİTAL İNSAN KAYNAKLARI

<div><div>S&uuml;rekli / Tam Zamanlı</div>
<div></div><div><b>Referans Numarası :</b> 1981-2041-2025
</div><div>İşe Alınacak Kişi Sayısı : 1</div>
<div></div><div><p>T&uuml;rkiye - İstanbul (Asya)
</p></div>
<div></div><div><p><b>Pozisyon Seviyesi : </b>:Orta D&uuml;zey Y&ouml;netici</p>
</div><div></div><div><p><b>İş Alanı : </b>: Ruhsatlandırma</p>
</div><div><div><h4 class="jobSectionHeader"><b>Genel Nitelikler ve İş Tanımı :</b></h4>
</div><div><p>As <b>Human Kapital</b>, on behalf of our corporate client operating in the pharmaceutical industry, we are seeking an <b>International Regulatory Affairs Manager</b> with strong experience in overseas regulatory processes, solid knowledge of global regulations, and proven team management capabilities.</p><p></p><p><b>
Required Qualifications</b></p><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field,</li><li>
Minimum 10 years of experience in the pharmaceutical industry,</li><li>
Prior experience in team management with demonstrated leadership skills,</li><li>
Preferably experienced in preparing overseas regulatory submission dossiers in <b>CTD format</b>,</li><li>
Strong knowledge of global regulations and international health authorities,</li><li>
Familiar with technology transfer processes and <b>R&amp;D (Product Development)</b> activities,</li><li>
Advanced level of English,</li><li>
Proficient in MS Office applications,</li><li>
Strong communication skills and a collaborative team player,</li><li>
For male candidates, completion of military service,</li></ul><p>
Able to reside in <b>Istanbul Ataşehir&ndash;Kadık&ouml;y</b> area or nearby districts.</p><p>
For Apply; https://humancapital.com.tr/ilan/143/international-regulatory-affairs-manager</p><p></p><p><b>
Duties and Responsibilities</b></p><ul><li>
Monitoring and implementing international regulatory requirements of relevant countries&rsquo; health authorities,</li><li>
Preparing overseas regulatory submission dossiers in compliance with country-specific requirements and managing the submission process,</li><li>
Following up all post-submission processes until product approval and ensuring internal coordination,</li><li>
Establishing effective communication with relevant health authorities,</li><li>
Preparing packaging mock-ups for products to be marketed abroad in accordance with the local language, and managing and tracking design approval processes,</li><li>
Notifying relevant country authorities of variations and changes made to licensed products,</li><li>
Tracking license renewal processes,</li><li>
Working in close cooperation with the Factory Quality Control unit,</li><li>
Contributing to R&amp;D processes,</li><li>
Following up variation approval processes,</li><li>
Managing and supervising the assigned team.</li></ul><p></p><p><b>
HUMAN KAPİTAL Human Resources and Consulting Services Industry and Trade Limited Company</b> is a private employment agency operating with the authorization of the Turkish Employment Agency dated <b>20.06.2025</b> and numbered <b>228</b>.<br>
In accordance with Law No. <b>4904</b> of the Turkish Employment Agency, no benefit of any kind may be obtained from job seekers.<br>
Charging job seekers any fee is strictly prohibited.</p>
</div></div><div><div><h4 class="jobSectionHeader"><b>Aday Kriterleri</b></h4>
</div><div><ul><li><b>İlan Tarihi : </b>15.12.2025</li>
<li><b>Eğitim Seviyesi: </b>Lisans Mezun, Y&uuml;ksek Lisans Mezun</li>
<li><b>Yaşadığı Şehir:</b> İstanbul (Asya),
</li><li><b>Tecr&uuml;be Yılı:</b> 10-0 Yıl</li>
<li><b>Yabancı dil ve seviyesi:</b> İngilizce - ( Seviye : İleri)<br>
</li><li><b>Askerlik Durumu:</b> Yapıldı, Muaf
</li><li><b>Firmanın Tercih Ettiği Sekt&ouml;rler :</b> İla&ccedil; &Uuml;retim ve Satışı</li></ul></div></div></div>

INTERNATIONAL REGULATORY AFFAIRS MANAGER

Keeta

<div>
 <p>
  I. Job Overview
 </p>
 <p>
  Recruit a motivated professional to support the company's government and regulatory affairs work in Oman.
 </p>
 <p>
  II. Job Responsibilities
 </p>
 <ol>
  <li>
   Establish and maintain cooperative relationships with ministries, regulatory authorities, and public sectors.
  </li>
  <li>
   Track updates on laws, regulations, and policies that affect business operations.
  </li>
  <li>
   Assist in handling government processes such as license applications, document submissions, and license renewals.
  </li>
  <li>
   Draft regulatory briefs, official letters, and response documents to authorities.
  </li>
  <li>
   Follow up on matters related to consumer protection, compliance requirements, and commercial practices.
  </li>
  <li>
   Conduct research on regulatory and economic topics relevant to Oman.
  </li>
  <li>
   Collaborate with internal teams (legal, operations, PR, compliance) to handle government-related affairs.
  </li>
 </ol>
 <p>
  III. Job Requirements
 </p>
 <p>
  Basic Requirements
 </p>
 <ol>
  <li>
   3+ years of work experience in government relations, regulatory affairs, compliance management, public sectors, or related fields.
  </li>
  <li>
   In-depth understanding of Oman&rsquo;s government structure, regulatory environment, and consumer protection frameworks.
  </li>
  <li>
   Excellent communication skills in both Arabic and English.
  </li>
  <li>
   Ability to handle multiple government processes accurately and professionally simultaneously.
  </li>
 </ol>
 <p>
  Preferred Qualifications
 </p>
 <ol>
  <li>
   Educational background or work experience in economics, legal/regulatory affairs, or public policy.
  </li>
  <li>
   Outstanding stakeholder management capabilities and administrative skills.
  </li>
 </ol>
 <p>
  IV. Job Highlights
 </p>
 <ol>
  <li>
   Opportunity to grow alongside the company&rsquo;s new business initiatives.
  </li>
  <li>
   Exposure to a diverse cultural work environment.
  </li>
 </ol>
 <p>
 </p>
</div>


Government & Regulatory Affairs manager

IQVIA

<p><b>No visa or accommodation sponsorship</b></p><p>You will be responsible for regulatory activities required at a country level for pharmaceutical products including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval, etc., ensuring regulatory compliance in the applicable market(s).</p><p>As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients, global pharmaceutical companies.</p><p><b>JOB OVERVIEW</b></p><p><b>Essential Functions</b></p><ol><li><b>Manage the local regulatory submission preparation</b> in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.</li><li><b>Submit submissions</b> such as renewals, variations, new applications, filings, MAH transfers to the local Health Authority and EMA, and follow up on the local regulatory approval process for designated countries.</li><li><b>Preparation of local Product Labelling</b> (e.g., SmPC, PIL) in local language for designated countries.</li><li><b>Artwork review and approval</b> in client systems.</li><li><b>Manage multiple pharmaceutical products.</b></li><li><b>Act as subject matter expert</b> in regulatory processes.</li><li>Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.</li><li>Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.</li><li>Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or <b>Lifecycle Maintenance / Marketing Authorization Transfers</b>/ Labeling/ Publishing.</li><li>Project budget management.</li><li>Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.</li><li>Possible exposure to present to clients on complex regulatory processes and bid defense meetings.</li><li>Act as reviewer for regulatory standard operating procedures.</li><li>Prepare and deliver internal regulatory training if required.</li></ol><p><b>MINIMUM REQUIRED EDUCATION AND EXPERIENCE</b></p><p><b>Experience:</b> Typically requires 8-10 years of prior relevant experience.</p><p><b>Education:</b> Masters Degree in Life Sciences or related discipline.</p><p><b>Skills and Abilities:</b></p><ul><li>Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.</li><li>Possesses specific regulatory or technical expertise.</li><li>Interpersonal communication (oral and written) and organization skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li><li>Demonstrates self-motivation and enthusiasm.</li><li>Ability to adapt quickly to a rapidly changing environment.</li><li>Knowledge of Maintenance of Marketing Authorization.</li><li>Experience of preparing variation renewal packages and artwork approvals.</li><li>Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.</li><li>Must be fluent in Arabic.</li></ul><p><b></b></p><p>IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at</p>

Global Regulatory Affairs Manager (homebased)

Kraft Heinz

<p></p><div><div><div><div><div><div><div><div><div><ul><div><b>All Posting Locations:</b> Besiktas, Istanbul, TR
</div><div><b>Job Functions:</b> Quality</div>
<div><b>Date Published:</b> December 30, 2025</div>
<div><b>Ref#:</b> R-97518</div></ul><div></div><div><br>
</div></div></div></div></div></div></div></div></div><p></p><div><div><div><div><div><div>ABOUT THE ROLE</div></div><div><div>
Job Description</div>
<p><b>About the Position</b></p>
<p>Regulatory Affairs Associate Manager ensuring Food Regulatory Compliance and enabling market access for products. Managing product registrations with authority, as well as reviewing, verifying product information and coordinating documentation for regulatory submissions. Supporting regulatory strategies, maintaining strong relationships with local authorities and internal stakeholders to support business growth. Monitoring and analyzing legislative/regulation changes and their impact on our products- brands- and organization. Presenting the organization in various trade associations and industry groups to proactively manage food regulatory advocacy as well as keeping internal stakeholders informed through continuous monitoring of emerging regulations. You&rsquo;ll be directly reporting into Head of Regulatory Affairs &ndash; East &amp; dotted-line reporting to Head of Legal T&uuml;rkiye.</p>
<p><b>Key Responsibilities</b></p>
<ul><li><p>Check the compliance of the products&rsquo; labels in Turkey against the relevant legislations- government guidelines and company policies. All brands the company produces and imports.</p>
</li><li><p>Check the compliance of the health and nutritional and other claims against the relevant legislation.</p>
</li><li><p>Support the Marketing team in providing and approving legislation of the products&rsquo; information relating to product functional &ndash; health &ndash; nutritional claims including ads and online marketing.</p>
</li><li><p>Provide information and advice on legislation for product formulation- packaging- and labelling issues.</p>
</li><li><p>Prepare product registration files with claim substantiation docs and follow up till registration is done.</p>
</li><li><p>Be in direct contact with distributors or get support from 3rd party companies (for export destinations) to support and understand any new regulatory updates/ requirements.</p>
</li><li><p>Support the business with regulatory information relating to products produced and sold in other regions.</p>
</li><li><p>Work with cross country teams to ensure regulatory compliance of export and import products including filling necessary applications.</p>
</li><li><p>Leading Regulatory Horizon Scanning for upcoming regulatory related changes for the business. Build and maintain relationships with the relevant industrial groups, authorities, and global horizon scan team to maintain awareness of new food legislations.</p>
</li><li><p>Leading Proactive &ndash; Raw Material Forecasting Model for upcoming regulatory changes for raw materials, those can have impact for the business, by monitoring regulatory changes in other regions. Proactively manage likelihood vs. business impact mapping, sharing criticality and regulatory forecasting map with cross functional team to take necessary actions for business readiness proactively.</p>
</li><li><p>Track- monitor and report completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.</p>
</li><li><p>Ensure that ingredients- formulas- labeling- and packaging are in full compliance with the local laws and regulations where the products are sold; and provide training to the organization on relevant regulatory topics.</p>
</li><li><p>Monitor and provide advice/analysis on best practices from the market for the categories we play in &amp; share it consistently with other RA teams across the company.</p>
</li><li><p>Participating in industrial groups regular meetings (Federation of Food &amp; Drink Industry Associations, Amcham Turkey Food &amp; Agriculture Committee, Salkonder) to proactively monitor and manage regulatory changes, analyzing their business impacts and developing advocacy strategies. Leading necessary internal communications with team to initiate compliance actions to prevent or minimize business risks from new laws.</p>
</li><li><p>Build strategic relationships with regulators and legislative bodies (Ministry of Agriculture and Forestry (MinAF), Directorate General for Food and Control (GDFC)) in Turkey by maintaining consistent communication with them to gain insights for upcoming regulatory changes and shape them (front of pack, nutritional labelling, food additives approvals, etc.).</p>
</li><li><p>Connecting to Kraft Heinz global horizon scan team to monitor upcoming regulation changes to identify risk or opportunities for the business.</p>
</li><li><p>Driving cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products. Supporting supply chain and custom agency team regarding product claim and compliance related documents.</p>
</li><li><p>Executing company-wide regulatory strategies, provide technical and strategic guidance, training to cross functional teams.</p>
</li></ul><p><b>Qualifications &amp; Experience</b></p>
<ul><li><p>Bachelor&rsquo;s degree in Food Technology/ Pharmacy or related disciplines. Master degree is an advantage</p>
</li><li><p>Minimum 5-10 years working experience in the field of regulatory affairs (Turkish Food Law, Turkish Food Codex, Codex Alimentarius, EU Regulations) preferably within an international FMCG environment.</p>
</li><li><p>Good understanding of the commercial drivers of F&amp;B industry and an associated ability to provide advice/guidance that takes these into consideration.</p>
</li><li><p>Building regulatory network internally and externally.</p>
</li><li><p>Familiar with Turkey food registration procedures and regulatory aspects.</p>
</li><li><p>Analytical skills and attention to detail with the capability to appropriately define issues, questions, and data</p>
</li><li><p>Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills</p>
</li><li><p>Ability to think strategically and act proactively for possible regulatory related risk for the business.</p>
</li><li><p>Commitment to continuous improvement in department processes and performance.</p>
</li><li><p>Strong team player, assisting others, having ability to build strong cross functional team network and cooperation.</p>
</li><li><p>Ability to work both independently and as part of a team as required.</p>
</li><li><p>Be able to balance company commercial needs with compliance requirements.</p>
</li><li><p>Excellent written, presentation and verbal communication skills.</p>
</li><li><p>Fluency in English and Turkish</p>
</li></ul><p>This position can be based in either Susurluk factory or İstanbul Headquarter.</p>
<p><b>About Us</b><br>
The Kraft Heinz Company is one of the largest food and beverage companies in the world, with eight $1 billion+ brands and global sales of approximately $25 billion. We&rsquo;re a globally trusted producer of high-quality, great-tasting, and nutritious foods for over 150 years. Our brands are truly global, with products produced and marketed in over 40 countries. These beloved products include condiments and sauces, cheese and dairy, meals, meats, refreshment beverages, coffee, infant and nutrition products, and numerous other grocery products in a portfolio of more than 200 legacy and emerging brands.</p>
<p>No matter the brand, we&rsquo;re united under one vision To sustainably grow by delighting more consumers globally. Bringing this vision to life is our team of 39,000+ food lovers, creative thinkers, and high performers worldwide. Together, we help provide meals to those in need through our global partnership with Rise Against Hunger. We also stand committed to responsible, sustainable practices that extend to every facet of our business, our consumers, and our communities. Every day, we&rsquo;re transforming the food industry with bold thinking and unprecedented results. If you share our passion &ndash; and are ready to create the future, build a legacy, and lead as a global citizen &ndash; there&rsquo;s only one thing to do join our table and let&rsquo;s make life delicious!</p>
<p><b>Our Culture of Ownership, Meritocracy and Collaboration</b></p>
<p>We're not afraid to think differently. Embrace new ideas. Dream big. We empower our people at every level &ndash; from entry-level intern to senior leader &ndash; to own their work. We share a responsibility to think like Owners &ndash; to be mindful of the collective and sustained success of Kraft Heinz &ndash; which we apply to every situation, every day.</p>
<p>As part of Kraft Heinz, you're supported to grow and achieve. You&rsquo;re expected to bring your authentic self to work every day, to lead with humility, and drive outstanding performance at every level &ndash; and you&rsquo;ll be rewarded. You&rsquo;re given opportunities to leave a mark and build a legacy. But you won&rsquo;t do it alone. You&rsquo;re supported by passionate teammates along the way, and our collective, collaborative spirit fuels our incredible progress.</p><br>
<p>We are proud to be a Great Place to Work certified company. Click to view our certificate: https://www.greatplacetowork.com.tr/sertifikasyon/sertifikali-sirketler/kraft-heinz-turkiye/</p>
<p>Employee Candidate Privacy Notice https //www.heinz.eu/turkey-candidate-privacy-policy</p>
<div>Location(s)</div>
<p>Istanbul Branch</p><p><br>
</p><p><b>Kraft Heinz is an Equal Opportunity Employer &ndash; Underrepresented Ethnic Minority Groups/Women/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity and other protected classes</b><b>.</b></p></div></div></div></div></div></div>

Regulatory Affairs Associate Manager

<div><div><div><div><div><div><b>Entity:</b> CSL Behring</div>
<div><b>Job Category:</b> Research Development &amp; Sciences</div>
<div><b>Job Family:</b> Global &amp; Regional Regulatory Affairs</div>
<div><b>Job Type:</b> Full Time</div>
<div><b>Location</b><b>:</b> Riyadh, Riyadh, Saudi Arabia</div>
<div><b>Employer Reference:</b> R-266747</div>
</div></div><div></div><h2 class="jobSectionHeader"><b>Job Description</b></h2>
<div><div><div><b>Main Responsibilities and Accountabilities</b></div><div><b>
1. Strategic Focus</b></div><ul><div><div>
Lead the development and execution of regulatory strategies for complex projects across KSA and MEA partner markets:</div></div><div><ul><div><div>
Assess regulatory pathways and identify optimal submission strategies to accelerate approvals while ensuring compliance with local and global requirements.</div></div><div><div>
Anticipate regulatory challenges and proactively design mitigation plans to minimize risks and delays.</div></div><div><div>
Align regulatory strategies with business objectives, product lifecycle plans, and commercial priorities to support timely market access.</div></div><div><div>
Collaborate with cross-functional teams (clinical, quality, manufacturing, commercial) to integrate regulatory considerations into project planning and decision-making.</div></div><div><div>
Drive innovative approaches to meet evolving regulatory requirements and leverage regional insights to influence global strategy.</div></div></ul></div></ul><div></div><ul><div><div><br>
Ensure oversight on key processes and frameworks to manage third-party activities end-to-end, ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance, and address deviations promptly.</div></div></ul><div></div><div><b><br>
2. Technical Regulatory Responsibilities for KSA (in Coordination with Scientific Office Manager)</b></div><ul><div><div>
Responsible for technical regulatory activities in KSA, while coordinating all actions with the Scientific Office Manager for the TSO in Saudi, including:</div></div></ul><ul><div><ul><div><div>
Performing regulatory assessments for new products and variations.</div></div><div><div>
Preparing and compiling complete regulatory dossiers in alignment with SFDA requirements.</div></div><div><div>
Managing electronic submissions through the SDR portal via the Scientific Office in KSA.</div></div><div><div>
Responding to SFDA queries and deficiency letters promptly and effectively.</div></div><div><div>
Ensuring compliance with all local regulatory standards and timelines for approvals.</div></div><div><div>
Maintaining proactive communication with SFDA to facilitate smooth review processes.</div></div></ul></div></ul><div></div><ul><div><div><br>
Also responsible for interaction with distributors and local partners for local manufacturing projects in KSA to ensure all regulatory activities are on track and aligned with compliance requirements.</div></div></ul><div><b>
3. Regulatory Oversight for Partner Markets in MEA (Assigned Markets)</b></div><ul><div><div>
Manage distributors and partners in assigned Partner Business markets.</div></div><div><div>
Prepare regulatory dossiers and provide regulatory assessments for these markets, ensuring compliance with local requirements and company standards.</div></div><div><div>
Ensure distributors submit dossiers to Health Authorities on time and in full compliance with regulatory requirements.</div></div><div><div>
Conduct audits and assessments to ensure compliance with local requirements and quality standards; implement corrective actions and risk mitigation strategies.</div></div><div><div>
Act as RA representative in audits/inspections and ensure readiness and timely CAPA closure.</div></div><div><div>
Serve as escalation point for partner-related issues and align closely with GRA for contract management.</div></div></ul><div><b>
4. Regulatory Intelligence &amp; Authority Interaction</b></div><ul><div><div>
Stay updated on regulatory requirements, guidelines, and industry trends; communicate changes to GRA and local teams.</div></div><div><div>
Communicate with Health Authorities, specifically SFDA, for all regulatory activities as needed, while ensuring coordination with the Scientific Office Manager.</div></div></ul><div><b>
5. Submission Management</b></div><ul><div><div>
Support regional regulatory teams in planning and submission preparation according to local requirements.</div></div><div><div>
Perform preparation and submission of regulatory dossiers, including variations, labeling, and NDAs, ensuring compliance with local regulations.</div></div><div><div>
Demonstrate strong knowledge of eCTD structure and requirements, including publishing tools (e.g., DocuBridge), eCTD compilation, and technical validation.</div></div><div><div>
Ensure familiarity with electronic submission processes through SDR in in Saudi Arabia ; maintain awareness of all technical aspects related to electronic submissions.</div></div></ul><div><b>
6. Systems &amp; Data Integrity</b></div><ul><div><div>
Maintain accurate and timely updates in regulatory systems and databases such as Veeva Vault RIM.</div></div><div><div>
Demonstrate advanced experience in Veeva, including:</div></div></ul><ul><div><ul><div><div>
Managing end-to-end regulatory workflows within Veeva Vault RIM.</div></div><div><div>
Uploading, organizing, and maintaining submission documents in compliance with global and local standards.</div></div><div><div>
Ensuring data integrity and version control for all regulatory records.</div></div><div><div>
Generating reports and dashboards to track submission status and compliance KPIs.</div></div><div><div>
Coordinating with global teams to ensure alignment of Veeva processes across regions.</div></div></ul></div></ul><div><b>
7. Labeling Responsibilities</b></div><ul><div><div>
Experience in end-to-end labeling processes, including country-specific labels and multi-country shared labels.</div></div><div><div>
Ensure compliance with local GCC labeling requirements.</div></div><div><div>
Coordinate labeling activities with other team members for MEA shared labels to ensure timely updates and consistency.</div></div><div><div>
Demonstrate knowledge of GLAMS labeling process and maintain accurate labeling records in the system.</div></div></ul><div><b>
8. Local Manufacturing Projects</b></div><ul><div><div>
Manage local manufacturing partners in KSA to ensure they are updated with the latest technical dossier of the product.</div></div><div><div>
Ensure partners perform regulatory activities on time, including variations, labeling updates, and registration renewals.</div></div><div><div>
Be actively involved in any new initiatives for local manufacturing in KSA and other MEA markets, providing regulatory guidance and support from planning through execution.</div></div></ul><div><b>
9. Stakeholder Management &amp; Training</b></div><ul><div><div>
Act as primary interface with local partners in assigned markets, representing the company&rsquo;s regulatory interests and fostering strong relationships.</div></div><div><div>
Align with commercial in Partner Business Markets to ensure timely and standardized delivery of partner-specific activities.</div></div><div><div>
Monitor training effectiveness and compliance; ensure proper training programs are developed and implemented.</div></div><div><div>
Lead and deliver complex regional strategies across CSL products, ensuring alignment with company and commercial objectives.</div></div><div><div>
Provide guidance for regulatory activities across MEA countries, adapting strategies to local requirements.</div></div></ul><div>
-</div><div><b>
Position Qualifications and Experience Requirements</b></div><div></div><div><b>
Education</b></div><ul><div><div>
Bachelor&rsquo;s degree in pharmacy, life sciences, or related field.</div></div><div><div>
Certifications in quality or vendor management (e.g., CQA, CMQ, CSQP) desirable.</div></div></ul><div></div><div><b><br>
Experience</b></div><ul><div><div>
Minimum 10+ years in regulatory affairs within pharmaceutical, biotechnology, or healthcare industry.</div></div><div><div>
Proven ability to develop and execute regulatory strategies for complex projects.</div></div><div><div>
Strong experience in communication and negotiation with Health Authorities, specifically SFDA.</div></div><div><div>
Hands-on experience in regulatory dossier preparation (variations, labeling, NDAs).</div></div><div><div>
Proficiency in regulatory systems and databases such as Veeva Vault RIM.</div></div><div><div>
Expertise in eCTD structure, publishing tools (e.g., DocuBridge), and electronic submission processes.</div></div><div><div>
Experience managing local manufacturing projects, particularly in KSA.</div></div><div><div>
Regional regulatory experience across multiple MEA countries.</div></div><div><div>
Demonstrated ability to work in a highly matrixed organization and establish successful cross-functional relationships.</div></div><div><div>
Experience in Pharmacovigilance is desirable.</div></div></ul><div></div><div><b><br>
Competencies</b></div><ul><div><div>
Fluent in Arabic and English (oral and written).</div></div><div><div>
Advanced MS Office skills.</div></div><div><div>
Strong organizational, time management, and interpersonal skills in a global environment.</div></div><div><div>
Ability to work independently and collaboratively, with strong problem-solving and decision-making skills.</div></div></ul></div>
</div><h2 class="jobSectionHeader"><b>About CSL Behring</b></h2>
<div>
<div>CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.</div>
<div>CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.</div>
<div>To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.</div>
</div>
<h2 class="jobSectionHeader"><b>Our Benefits</b></h2>
<div>
<div>For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.</div>
</div>
<h2 class="jobSectionHeader"><b>You Belong at CSL</b></h2>
<div>
<div>At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.</div>
<div>To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging</div>
</div>
<h2 class="jobSectionHeader"><b>Equal Opportunity Employer</b></h2>
<div>
<div>CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.</div></div></div></div></div><div></div>

Regulatory Affairs Senior Manager, GRA, RPR MEA

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

Novo Nordisk, Inc.

<div><div><div><div><div><p>Regulatory Affairs Product Lead, T&uuml;rkiye (Fixed-Term Contract)
</p></div></div></div></div><div><div><div><div><b>Category: </b>Reg Affairs &amp; Safety Pharmacovigilance
</div></div></div></div><div><div><div><div><b>Location:
</b>İstanbul, Marmara Region, TR<br>
</div></div></div></div><div></div><div><div><div><div><div>This is the opportunity that have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders as our new Regulatory Affairs Product Lead in Novo Nordisk T&uuml;rkiye. This position is a fixed term for 12 months (maternity cover), based in Istanbul, and reports to the Head of Regulatory Affairs and Pharmacovigilance.</div><div><br>
<b>
Your new position</b></div>
<div>
As the Regulatory Affairs Product Lead, you will be responsible for developing the regulatory strategy for innovative products, managing new registration files, technical variations, labelling and safety updates of product registration files and GMP files, in a timely manner and responding effectively to all product registration modifications requested by the HQ/local health authority. You will always act in alignment with our Novo Nordisk Way and demonstrate knowledge of the health care system in Turkey.</div><div><br>
You will be also responsible for
</div><ul><li>Conducting the translation, compilation, submission and follow-up related to all NN registration processes</li>
<li>Holding the responsibility for ensuring that the regulatory tasks are completed in compliance with the NN Corporate Quality Procedures, local regulations and business needs. Accompanying GMP inspection with inspector and conducting all GMP process and communication with stakeholders for assigned manufacturing sites.
</li><li>Being a coherent business partner for the business units, initiate effective cross-functional collaborations for fast regulatory approvals, creating and keeping competitive labels. In addition, you will represent Regulatory Affairs in internal brand teams by providing input on strategy and actions.</li>
<li>Monitoring competitive intelligence on relevant therapeutic areas and local environment for developments in regulations and providing relevant information to key internal and external stakeholders and advising on necessary actions about changing regulations.</li></ul><br>
<div><br>
<b>Your new department</b></div>
<div>
The Clinical, Medical, Regulatory (CMR) department provides timely, accurate, and updated services to support Novo Nordisk in all therapeutic areas. The Clinical, Medical, Regulatory Department is a team of skilled and committed specialists within medical, clinical, regulatory, and safety areas. Regulatory Affairs Unit is responsible for local strategies to obtain and maintain marketing authorisations for Novo Nordisk&rsquo;s new products and life cycle management activities such as new indications and GMP processes. We aim to be the best Regulatory Affairs unit in the global pharma industry, being true business partners and continuously improving our performance while offering our people a great place to work.</div><br>
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<div><b>
Your skills &amp; qualifications</b></div>
<div>
You are expected to hold a university degree in Pharmacy, Chemical Engineering, Chemistry, Biology or Medical. You have minimum 3 years of proven experience in regulatory affairs in pharma industry and you should have advanced level of written and spoken English and Turkish. Further sought-after skills are</div><br>
<div></div>
<ul>
<li>You have the ability to manage multiple projects and submissions simultaneously and prioritize workload to meet business deadlines</li>
<li>You have an excellent communication and stakeholder management abilities and effective time management skills, can do mindset</li>
<li>You have good analytical capability and strategical thinking mindset and eagerness to learn influence the organization to move forward</li></ul><br>
<div></div>
<div><b>
Working at Novo Nordisk</b></div>
<div>
At Novo Nordisk, we don&rsquo;t wait for change. We drive it. We&rsquo;re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales &ndash; we&rsquo;re all working to move the needle on patient care.</div><br>
<div></div>
<div><b>
What We Offer</b></div>
<div>
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.</div><br>
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<div><b>
D</b><b>eadline</b></div>
<div>
Apply before 31st December 2025. Applications are reviewed on an ongoing basis</div><div></div><div><br>
<i>
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.</i></div><div></div><div><br>
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.</div><br>
<div></div>
<div>
We&rsquo;re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.</div></div></div></div></div></div>

Regulatory Affairs Product Lead, Türkiye (Fixed-Term Contract)

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