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senior regulatory affairs specialist - egypt

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regulatory affairs senior associate

Viatris

<div>
 <p>
  At VIATRIS&trade;, 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.
 </p>
 <p>
  <br/>
 </p>
 <p>
  Viatris empowers people worldwide to live healthier at every stage of life.
 </p>
 <p>
  <br/>
 </p>
 <p>
  We do so via:
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   <strong>
    Access
   </strong>
   &ndash; Providing high quality trusted medicines regardless of geography or circumstance.
  </li>
  <li>
   <strong>
    Leadership
   </strong>
   &ndash; Advancing sustainable operations and innovative solutions to improve patient health; and
  </li>
  <li>
   <strong>
    Partnership
   </strong>
   &ndash; Leveraging our collective expertise to connect people to products and services.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  Every day, we rise to the challenge to make a difference and here&rsquo;s how the (Regulatory Affairs Senior Associate) role will make an impact:
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key responsibilities for this role include:
  </strong>
 </p>
 <ul>
  <li>
   Support the local regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management.
  </li>
  <li>
   Develop strong partnerships with in-country and above country teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
  </li>
  <li>
   Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.
  </li>
  <li>
   Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP&rsquo;s and systems are followed.
  </li>
  <li>
   Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners.
  </li>
  <li>
   Capable of authoring some local submission components in relevant databases.
  </li>
  <li>
   Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.
  </li>
  <li>
   Liaise with the manufacturing sites for obtaining supporting documents as needed.
  </li>
  <li>
   Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance, innovation and talent development and retention.
  </li>
  <li>
   Maintain compliance with the regulatory systems, processes and procedures.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   The minimum qualifications for this role are:
  </strong>
 </p>
 <ul>
  <li>
   2-3 years of experience in regulatory affairs, preferably in human medicines.
  </li>
  <li>
   Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
  </li>
  <li>
   Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
  </li>
  <li>
   Demonstrate experience of effective delivery in a matrix environment.
  </li>
  <li>
   Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
  </li>
  <li>
   Knowledge of drug development, regulations, and guidelines.
  </li>
  <li>
   Knowledge and understanding of quality systems and processes.
  </li>
  <li>
   Ability to influence peers in the organization.
  </li>
  <li>
   Team player.
  </li>
  <li>
   Act independently with less supervision.
  </li>
  <li>
   Analytical thinking.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  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.
 </p>
</div>


Regulatory Affairs Senior Associate

<div>Viatris Egypt S.A.E<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>
<br>
Viatris empowers people worldwide to live healthier at every stage of life.<br>
<br>
We do so via:<br>
<br>
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 Affairs Senior Associate) role will make an impact:</div><div><br>
Key responsibilities for this role include:</div><ul><li><div>
Support the local regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management.</div></li><li><div>
Develop strong partnerships with in-country and above country teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.</div></li><li><div>
Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.</div></li><li><div>
Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP&rsquo;s and systems are followed.</div></li><li><div>
Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners.</div></li><li><div>
Capable of authoring some local submission components in relevant databases.</div></li><li><div>
Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.</div></li><li><div>
Liaise with the manufacturing sites for obtaining supporting documents as needed.</div></li><li><div>
Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance, innovation and talent development and retention.</div></li><li><div>
Maintain compliance with the regulatory systems, processes and procedures.</div></li></ul><div></div><div>
The minimum qualifications for this role are:</div><ul><li><div>
2-3 years of experience in regulatory affairs, preferably in human medicines.</div></li><li><div>
Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.</div></li><li><div>
Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.</div></li><li><div>
Demonstrate experience of effective delivery in a matrix environment.</div></li><li><div>
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.</div></li><li><div>
Knowledge of drug development, regulations, and guidelines.</div></li><li><div>
Knowledge and understanding of quality systems and processes.</div></li><li><div>
Ability to influence peers in the organization.</div></li><li><div>
Team player.</div></li><li><div>
Act independently with less supervision.</div></li><li><div>
Analytical thinking.</div></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>

Jamjoom Pharma

<div><p><b>Role Overview</b></p><p>
We are seeking a highly experienced and scientifically driven <b>Senior Medical Advisor &ndash; Cardiometabolic</b> to lead medical strategy and high-impact scientific engagement across Egypt. This role requires deep expertise in cardiometabolic diseases and the ability to act as a trusted internal and external medical authority.</p><p>
The Senior Medical Advisor will play a pivotal role in shaping local medical strategy, driving insight generation, supporting evidence-based decision-making, and ensuring the highest standards of medical governance, compliance, and scientific integrity. The role includes strategic leadership, senior KOL engagement, and mentoring within Medical Affairs.</p><p></p><p><b><br>
Key Responsibilities</b></p><ul><li>
Act as a <b>senior medical and scientific expert</b> in cardiometabolic therapeutic areas, including diabetes, obesity, cardiovascular disease, dyslipidemia, and hypertension.</li><li>
Lead the <b>development and execution of local medical strategies and medical plans</b>, aligned with global and regional objectives.</li><li>
Serve as a <b>trusted scientific partner</b> to national and regional KOLs, academic institutions, and key healthcare stakeholders across Egypt.</li><li>
Oversee and ensure high-quality, <b>non-promotional scientific exchange</b>, including communication of clinical trial data, real-world evidence, and disease-state education.</li><li>
Generate, analyze, and synthesize <b>medical insights</b> from the field to inform medical strategy, evidence generation, and lifecycle management.</li><li>
Provide senior medical leadership for <b>advisory boards, scientific meetings, congresses, and symposia</b>.</li><li>
Support and provide medical oversight for <b>clinical trials, investigator-initiated studies (IIS), real-world evidence, and post-marketing activities</b>, as applicable.</li><li>
Ensure accurate, timely, and compliant responses to <b>unsolicited medical inquiries</b>, in accordance with regulatory and company standards.</li><li>
Act as a <b>medical reference point and mentor</b> for MSLs and junior medical colleagues, contributing to capability building and best practice sharing.</li><li>
Collaborate closely with <b>Regulatory Affairs, Market Access, Pharmacovigilance, and Commercial teams</b>, while maintaining full medical independence.</li><li>
Ensure full compliance with <b>Egyptian Drug Authority (EDA) regulations</b>, company SOPs, pharmacovigilance requirements, and ethical standards.</li><li>
Maintain up-to-date knowledge of <b>local and international treatment guidelines</b>, clinical literature, and the competitive landscape in cardiometabolic care.</li></ul><p></p><p><b><br>
Qualifications &amp; Requirements</b></p><p><b>
Education</b></p><ul><li>
Bachelor&rsquo;s degree in <b>pharmacy or medicine</b> (mandatory).</li><li>
Advanced degrees (PharmD, MSc, PhD, or MD) are <b>strongly preferred</b>.</li><li>
Formal training in Medical Affairs, Clinical Research, or Evidence-Based Medicine is an advantage.</li></ul><p><b>
Experience</b></p><ul><li>
Minimum <b>5 years of experience in Medical Affairs</b> within the pharmaceutical industry. (Senior MSL, Medical Advisor, or equivalent), preferably in cardiometabolic or chronic disease areas.</li><li>
Proven experience engaging <b>senior KOLs, investigators, and academic leaders</b> in Egypt.</li><li>
Experience within <b>multinational pharmaceutical companies</b> is a strong advantage.</li><li>
Demonstrated involvement in <b>clinical trials, advisory boards, and major scientific congresses</b>.</li></ul><p></p><p><b><br>
Skills &amp; Competencies</b></p><ul><li><b>
Therapeutic Expertise:</b> Deep scientific and clinical understanding of cardiometabolic diseases and evolving treatment paradigms.</li><li><b>
Medical Strategy &amp; Leadership:</b> Ability to shape and execute impactful medical strategies at a country level.</li><li><b>
Scientific Communication:</b> Strong capability to communicate complex clinical data clearly, credibly, and compliantly.</li><li><b>
Stakeholder Engagement:</b> Trusted relationship builder with KOLs, investigators, and healthcare decision-makers.</li><li><b>
Insight Generation &amp; Analytics:</b> Ability to translate field insights into actionable strategic recommendations.</li><li><b>
Cross-Functional Influence:</b> Effective collaboration across internal stakeholders while safeguarding medical integrity.</li><li><b>
Compliance &amp; Ethics:</b> Strong knowledge of EDA regulations, pharmacovigilance, and ethical standards in Egypt.</li><li><b>
People Development:</b> Experience mentoring and developing MSLs and junior medical team members.</li><li><b>
Language Skills:</b> Fluency in <b>English</b> (written and spoken); <b>Arabic fluency is required</b> for local engagement.</li></ul></div><p></p>

Senior Medical Advisor - Cardiometabolic

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><p><b>Role Overview</b></p><p>
We are seeking a detail-oriented and proactive <b>Export Regulatory Affairs Specialist</b> to support global regulatory compliance and international market access. This role is critical in managing export regulatory submissions, ensuring adherence to country-specific requirements, and coordinating cross-functionally to facilitate timely and compliant product exports.</p><p></p><p><b><br>
Key Responsibilities</b></p><ul><li>
Compile, format, and submit dossiers in CTD/eCTD format, ensuring accuracy, consistency, and compliance with international standards.</li><li>
Manage Certificates of Pharmaceutical Product (CPP) issuance and legalization processes.</li><li>
Ensure compliance with export regulations, customs requirements, and country-specific guidelines.</li><li>
Liaise with agents, distributors, and internal teams to resolve regulatory queries.</li><li>
Maintain up-to-date knowledge of global regulatory frameworks and changes impacting exports.</li><li>
Support audits, inspections from export countries.</li><li>
Develop and optimize workflows for regulatory submissions and export documentation.</li></ul><p></p><p><b><br>
Qualifications &amp; Requirements</b></p><p><b>
Education</b></p><ul><li>Bachelor&rsquo;s degree in <b>pharmacy, Life Sciences</b>, or a related field (mandatory).</li><li>Additional training or certification in Regulatory Affairs is considered a plus.</li></ul><p></p><p><b><br>
Experience</b></p><ul><li><b>3&ndash;5 years</b> of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on <b>export submissions</b>.</li><li>Proven experience in <b>CTD/eCTD dossier preparation, publishing, and submission</b> for international markets.</li><li>Solid knowledge of international regulatory requirements and export-related guidelines.</li><li>Experience working with agents and distributors across multiple countries is an advantage.</li></ul><p></p><p><b><br>
Skills &amp; Competencies</b></p><ul><li><b>Regulatory Expertise:</b> Strong understanding of global regulatory frameworks and export compliance requirements.</li><li><b>Technical Writing:</b> Excellent ability to prepare clear, accurate, and compliant regulatory documentation.</li><li><b>Communication:</b> Fluent in <b>English</b> (written and spoken); <b>French language skills are required</b>.</li><li><b>Organization &amp; Attention to Detail:</b> High level of accuracy in managing multiple dossiers and regulatory documents.</li><li><b>Cross-functional Collaboration:</b> Ability to work effectively with internal teams and external partners.</li><li><b>Systems &amp; Tools:</b> Proficient in documentation management systems and <b>MS Office</b> applications.</li><li><b>Problem Solving:</b> Proactive in identifying issues and driving timely regulatory solutions.</li><li><b>Integrity &amp; Compliance:</b> Demonstrates strong ethical standards and commitment to regulatory compliance.</li></ul></div>

Export Regulatory Affairs Specialist

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>

Explore 718+ Regulatory affairs senior associate in Egypt this January. Find roles across top companies and apply now to boost your career.

718 regulatory affairs senior associate jobs IN Egypt

Regulatory Affairs Senior Associate

Regulatory Affairs Senior Associate

Senior Medical Advisor - Cardiometabolic

Regulatory Specialist, SARA

Export Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist - Egypt

Senior Regulatory Affairs Specialist - Egypt