manager of regulatory affairs

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

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

IQVIA

<div><div><div>New Cairo, Egypt | Full time | Hybrid | R1521166</div></div><p></p><div><div><br>
We are hiring for a Senior Regulatory Role and are looking for an individual contributor who is proficient in regulatory knowledge and can work with a high sense of ownership under limited supervision. The role covers Egypt (experience in imported pharmaceutical and biological products), Libya, the GCC, and Jordan.</div><div>
This role reports to the Regulatory Affairs Manager and is based in Egypt.</div><div><b>
Scope of Work</b></div><ul><li><div>
Egypt, Libya, Jordan, and GCC regulatory experience is required.</div></li><li><div>
Act as a Regional Regulatory Affairs Strategist on complex regulatory projects, developing and implementing country-level strategies in Egypt, Libya, Jordan, and the GCC.</div></li><li><div>
Experience in both pharmaceuticals and biologicals is mandatory; medical device experience is a plus.</div></li><li><div>
Experience with reliance regulations in Egypt and the GCC is essential.</div></li></ul><div><b>
Responsibilities</b></div><ul><li><div>
Prepare, review, and submit regulatory documentation (e.g., CTD and eCTD submissions); ensure follow-through on post-approval commitments.</div></li><li><div>
Maintain product licenses in designated countries by overseeing all regulatory activities, including site registration and renewal, tender support, variations (CMC, labeling, MAT, administrative), product renewals, and withdrawals.</div></li><li><div>
Review promotional materials for compliance with Health Authority (HA) requirements and ensure relevant HA approvals are obtained.</div></li><li><div>
Possess good knowledge of pharmacovigilance requirements in relevant countries.</div></li><li><div>
Engage with health authority officials as needed and represent the client.</div></li><li><div>
Establish strong relationships with stakeholders, present regulatory projects and progress, and discuss issues and customer feedback.</div></li><li><div>
Act as a subject matter expert in regulatory knowledge implementation for lifecycle maintenance, marketing authorization transfers, labeling, publishing, change assessments, and other relevant areas.</div></li><li><div>
Stay updated with regulatory intelligence information from different health authorities, communicate insights to clients and working groups, and define the best strategies while anticipating future trends.</div></li><li><div>
Understand the scope of work, deliverables, and management of budgets for several projects; manage workload appropriately.</div></li><li><div>
Provide guidance to junior colleagues, including feedback on technical documents and assistance with their training, development, onboarding, and internships.</div></li><li><div>
Perform other tasks or assignments as delegated by Regulatory Management.</div></li></ul><div><b>
Qualifications</b></div><ul><li><div>
Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.</div></li><li><div>
High proficiency in English and Arabic is essential; French proficiency is a plus.</div></li><li><div>
At least 3-5 years of relevant regulatory experience in a national or regional scope of work.</div></li><li><div>
Good understanding of regulations and related guidelines in the Gulf, Egypt, and Jordan.</div></li><li><div>
Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.</div></li><li><div>
Familiarity with different regulatory dossiers (CTD, eCTD, NeeS) is a must.</div></li><li><div>
Ability to read and understand high-level SOPs and e-trainings and to learn quickly within tight onboarding timelines.</div></li><li><div>
Tech-savvy with proficiency in Veeva, digital workspace tools, publishing applications, Power BI, Task Planner, SharePoint, and other Microsoft Office tools; ability to collaborate effectively.</div></li><li><div>
Knowledge of pharmaceutical industry operations.</div></li><li><div>
Strong interpersonal communication and organizational skills.</div></li><li><div>
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</div></li><li><div>
Demonstrates self-motivation, enthusiasm, and a high sense of ownership.</div></li><li><div>
Organized with meticulous attention to detail to ensure accuracy in documentation and compliance.</div></li></ul><div>
If you believe you can bring adaptability to a rapidly changing environment, a problem-solving attitude, and a readiness to continuously upgrade your skills, please apply.</div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div></div></div><div></div>

Senior Regulatory Affairs Specialist - Egypt

<p></p><div><p>We are hiring for a Senior Regulatory Role and are looking for an individual contributor who is proficient in regulatory knowledge and can work with a high sense of ownership under limited supervision. The role covers Egypt (experience in imported pharmaceutical and biological products), Libya, the GCC, and Jordan.</p><p></p><p>
This role reports to the Regulatory Affairs Manager and is based in Egypt.</p><p><b>
Scope of Work</b></p><ul><li><p>
Egypt, Libya, Jordan, and GCC regulatory experience is required.</p></li><li><p>
Act as a Regional Regulatory Affairs Strategist on complex regulatory projects, developing and implementing country-level strategies in Egypt, Libya, Jordan, and the GCC.</p></li><li><p>
Experience in both pharmaceuticals and biologicals is mandatory; medical device experience is a plus.</p></li><li><p>
Experience with reliance regulations in Egypt and the GCC is essential.</p></li></ul><p></p><p><b>
Responsibilities</b></p><ul><li><p>
Prepare, review, and submit regulatory documentation (e.g., CTD and eCTD submissions); ensure follow-through on post-approval commitments.</p></li><li><p>
Maintain product licenses in designated countries by overseeing all regulatory activities, including site registration and renewal, tender support, variations (CMC, labeling, MAT, administrative), product renewals, and withdrawals.</p></li><li><p>
Review promotional materials for compliance with Health Authority (HA) requirements and ensure relevant HA approvals are obtained.</p></li><li><p>
Possess good knowledge of pharmacovigilance requirements in relevant countries.</p></li><li><p>
Engage with health authority officials as needed and represent the client.</p></li><li><p>
Establish strong relationships with stakeholders, present regulatory projects and progress, and discuss issues and customer feedback.</p></li><li><p>
Act as a subject matter expert in regulatory knowledge implementation for lifecycle maintenance, marketing authorization transfers, labeling, publishing, change assessments, and other relevant areas.</p></li><li><p>
Stay updated with regulatory intelligence information from different health authorities, communicate insights to clients and working groups, and define the best strategies while anticipating future trends.</p></li><li><p>
Understand the scope of work, deliverables, and management of budgets for several projects; manage workload appropriately.</p></li><li><p>
Provide guidance to junior colleagues, including feedback on technical documents and assistance with their training, development, onboarding, and internships.</p></li><li><p>
Perform other tasks or assignments as delegated by Regulatory Management.</p></li></ul><p></p><p><b>
Qualifications</b></p><ul><li><p>
Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.</p></li><li><p>
High proficiency in English and Arabic is essential; French proficiency is a plus.</p></li><li><p>
At least 3-5 years of relevant regulatory experience in a national or regional scope of work.</p></li><li><p>
Good understanding of regulations and related guidelines in the Gulf, Egypt, and Jordan.</p></li><li><p>
Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.</p></li><li><p>
Familiarity with different regulatory dossiers (CTD, eCTD, NeeS) is a must.</p></li><li><p>
Ability to read and understand high-level SOPs and e-trainings and to learn quickly within tight onboarding timelines.</p></li><li><p>
Tech-savvy with proficiency in Veeva, digital workspace tools, publishing applications, Power BI, Task Planner, SharePoint, and other Microsoft Office tools; ability to collaborate effectively.</p></li><li><p>
Knowledge of pharmaceutical industry operations.</p></li><li><p>
Strong interpersonal communication and organizational skills.</p></li><li><p>
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</p></li><li><p>
Demonstrates self-motivation, enthusiasm, and a high sense of ownership.</p></li><li><p>
Organized with meticulous attention to detail to ensure accuracy in documentation and compliance.</p></li></ul><p></p><p>
If you believe you can bring adaptability to a rapidly changing environment, a problem-solving attitude, and a readiness to continuously upgrade your skills, please apply.</p><p></p><p>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</p></div>

Qiddiya | القدية

<div>
 <strong>
  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.
  <br/>
  <br/>
 </strong>
 <strong>
  General Summary:
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <strong>
  Essential Duties and Responsibilities:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Support the Associate Director in managing approvals and permits from regulatory authorities
  </li>
  <li>
   Coordinate development of regulatory documents and responses to government inquiries
  </li>
  <li>
   Track and report on regulatory changes impacting transport projects
  </li>
  <li>
   Build working relationships with government officials and regulatory entities
  </li>
  <li>
   Support internal project teams with regulatory guidance and interface planning
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Requirements
  <br/>
  <br/>
 </strong>
 <strong>
  Qualifications:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor's degree in Public Policy, Law, Political Science, Transport Planning, or related discipline
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Years of Experience:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   8+ years in regulatory affairs, permitting, or policy advisory in a transport or infrastructure setting
  </li>
 </ul>
</div>


Senior Manager - Regulatory and Policy (CDU3) - CDUP 2064

Amgen

Associate Regulatory Affairs - based in Dubai <p>Join to apply for the <b>Associate Regulatory Affairs - based in Dubai</b> role at <b>Amgen</b>.</p><p>You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.</p> What You Will Do <p>Let's do this. Let's change the world. In this vital role, you will manage country specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance:</p><ul><li>Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements</li><li>Reviews promotional and non promotional materials.</li><li>Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.</li><li>Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li></ul> What We Expect Of You <p>We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications.</p> Basic Qualifications <ul><li>Bachelor's degree in Pharmaceutical Science</li><li>Working with policies, procedures and SOPs.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Knowledge of the Gulf legislation and regulations.</li><li>Understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Understanding of drug development.</li><li>Demonstrate ability to work in teams.</li><li>Ability to understand and communicate scientific/clinical information.</li></ul> Preferred Qualifications <ul><li>Regulatory experience of the Gulf Markets.</li><li>Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>Experience interacting with regulatory agency in the Gulf markets.</li></ul> What You Can Expect Of Us <p>As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p><p>Apply now at </p><p>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p>

Associate Regulatory Affairs - based in Dubai

Mobilink Bank

<div>
 <p>
  <strong>
   Department:
  </strong>
  Regulatory Compliance
 </p>
 <p>
  <strong>
   Reports To:
  </strong>
  Chief Ethics &amp; Compliance Officer
 </p>
 <p>
  <strong>
   Job Grade: SVP
  </strong>
 </p>
 <p>
  <strong>
   Total Position:
  </strong>
  01
 </p>
 <p>
  <strong>
   Location:
  </strong>
  Head Office
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   What is Head Regulatory Affairs - MMBL?
  </strong>
 </p>
 <p>
  We are looking for someone to lead Mobilink Bank&rsquo;s engagement with government bodies, regulators, and law enforcement agencies to safeguard the Bank&rsquo;s interests and ensure compliance. The role advises senior management on regulatory changes, oversees timely reporting, and strengthens the bank&rsquo;s reputation through effective stakeholder management. It requires strong analytical, negotiation, and communication skills along with significant experience in regulatory affairs.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Responsibilities
  </strong>
 </p>
 <ul>
  <li>
   To work with internal and external stakeholders including Government Officials, Law Enforcement Agencies (LEAs) and all functions of the Bank through effective engagement, planning for sharing information, influencing and negotiating.
  </li>
  <li>
   Present Bank&rsquo;s position on to government authorities including LEAs to safeguard Bank&rsquo;s interests
  </li>
  <li>
   Advise Bank&rsquo;s senior management on implications of any changes in regulatory environment /policies of government authorities
  </li>
  <li>
   To maintain close Coordination with LEAs and present Bank&rsquo;s view Point in collaboration with designated departments and highlight issues or concerns noted by LEAs during the course of their investigations and ensure timely follow up for resolution. Provide input to Senior Management on engagement efforts with LEAs and possible implications for Bank and ensure efforts for mitigation and safeguarding the bank&rsquo;s interests
  </li>
  <li>
   Coordination with DFS counterparts to mitigate any regulatory bottle necks
  </li>
  <li>
   Develop and maintain a positive perception of MMBL and JazzCash Brand in the relevant circles i.e. ministries, regulatory authorities, LEAs and provincial government etc.
  </li>
  <li>
   Supervise timely and accurate reporting of information to LEAs, related to Branch/Branchless Banking Transactions/Frauds or any other area of operations
  </li>
  <li>
   To prepare reports/MIS/Dashboards for review of Head Regulatory Compliance/CE&amp;CO
  </li>
  <li>
   Must have fair knowledge of Corporate Communications, Reputational risk management and ensuring image management.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Requirements:
  </strong>
 </p>
 <ul>
  <li>
   Hold at least Bachelor&rsquo;s degree in Law, Computer Sciences, Commerce, Business Administration, or Economics etc.
  </li>
  <li>
   Having 8-10 years of relevant experience in senior roles with responsibility of regulatory affairs, government relations, and stakeholder management.
  </li>
  <li>
   Ability to analyze complex business and regulatory issues and provide expert opinion.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Essential Skills:
  </strong>
 </p>
 <ul>
  <li>
   Proficient in MS Office
  </li>
  <li>
   Strong analytical skills
  </li>
  <li>
   Team management
  </li>
  <li>
   Negotiation skills
  </li>
  <li>
   Customer Relationship
  </li>
  <li>
   Ability to work under pressure
  </li>
  <li>
   Sound communication and interpersonal skills
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Desirable Skills:
  </strong>
 </p>
 <ul>
  <li>
   Skilled in business planning, retail banking and customer service
  </li>
  <li>
   Thorough understanding of compliance and regulatory requirements for bank
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   About MMBL:
  </strong>
 </p>
 <p>
  Mobilink Microfinance Bank Ltd. is providing banking services to over 48 million registered users including 20+ million monthly active customers across Pakistan. With a hybrid model that combines traditional microfinance with mobile/digital banking technologies, the bank now operates with over 114 branches and 270,000 branchless banking agents and provides a USSD (GSM) based digital channel offering savings, micro enterprise (MSME) loans, small housing loans, remittances, collection (utility bills and loan instalments), mobile wallets, insurance, G2P, B2B &amp; B2P payments; thus, playing a leading role in the promotion of financial inclusion. MMBL is committed to fostering a positive and productive workplace, and our core values reflect this focus. These values include promoting innovation and entrepreneurship, encouraging teamwork and collaboration, and prioritizing a customer-centric approach in all aspects of our business.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Why Join MMBL?
  </strong>
 </p>
 <p>
  This is an opportunity for someone who is passionate about making a difference and playing a key role in driving transformative change. Our team is committed to empowering millions with the tools necessary to succeed in the digital age, and we're looking for a talented individual to join us in this endeavour.
 </p>
</div>


Head Regulatory Affairs

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