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regulatory manager regional projects cmc

<div>
 <strong>
  Site Name:
 </strong>
 Poznan Grunwaldzka, Bangalore, Egypt - Cairo
 <br/>
 <br/>
 <strong>
  Posted Date:
 </strong>
 Dec 12 2025
 <br/>
 <br/>
 <strong>
  Regulatory Project Manager , Regional Projects Team, CMC Excellence
  <br/>
  <br/>
 </strong>
 <em>
  Within the CMC RA group, the Regional Projects team bring together the operation and execution aspects for key regulatory deliverables for new Directives and Guidelines issued in Regions such as the implementation of eCTD Baselining, general Baselining, Localisation initiatives, and Re- Registrations. The Regional Projects team provide regulatory support across the Regions to deliver Submissions as stipulated in the new HA Directives for pharmaceutical, biopharm and vaccines products.
  <br/>
  <br/>
 </em>
 As Regulatory Manager, Regional Projects CMC you will have managerial responsibility for a direct reports as well as accountability and lead for the completion of assigned projects in the CMC Rx and Vx regulatory area. You will work with Head and Manager of Regional Projects as well as with Establish Products Teams to deliver Team&rsquo;s objectives.
 <br/>
 <br/>
 <strong>
  <em>
   This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following&hellip;
   <br/>
   <br/>
   <br/>
  </em>
 </strong>
 <ul>
  <li>
   Managing people aspects of a team of direct reports to create and sustain an efficient and motivating working environment
  </li>
  <li>
   Take accountability for tracking, analyzing and reporting of team performance against departmental KPIs
  </li>
  <li>
   Ensure proper escalation for resource or quality considerations
  </li>
  <li>
   Independently assess, manage, and/or drive the CMC strategy, coordinate, timely preparation, and author multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the Regional Directives and evolving regulatory requirements.
  </li>
  <li>
   Understand internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to Localisation projects, and provide guidance to R&amp;D teams, Quality Control, GSC, QA and LOC.
  </li>
  <li>
   Ensure adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus.
  </li>
  <li>
   Ensure adequate contribution during interactions with Worldwide Regulatory Authorities.  Authors responses to Regulatory Agency questions.
  </li>
  <li>
   Identify risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.
  </li>
  <li>
   Contribute to, and lead (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems.
  </li>
  <li>
   Ensure information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.
  </li>
  <li>
   Independently manage the completion of data assessment, ensure all appropriate CMC regulatory aspects, serve as dossier approver, identify improvement opportunities, and confidently execute a dossier that is fit for purpose per agreed dossier strategy and timelines.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  <em>
   Why you?
   <br/>
   <br/>
  </em>
 </strong>
 <strong>
  <em>
   Basic Qualifications:
   <br/>
   <br/>
   <br/>
  </em>
 </strong>
 <ul>
  <li>
   Master&rsquo;s degree or higher in a relevant scientific discipline.
  </li>
  <li>
   Experience in an international regulatory environment or working with multiple markets.
  </li>
  <li>
   Sound understanding of pharmaceutical industry and regulatory processes with expertise in CMC area
  </li>
  <li>
   Project Management experience
  </li>
  <li>
   Capability to build and maintain a team
  </li>
  <li>
   Fluent English
  </li>
  <li>
   Strong interpersonal and communication skills
  </li>
  <li>
   Ability to perform multiple tasks, set the right priorities to deliver objectives on time
  </li>
  <li>
   Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.
  </li>
  <li>
   Exceptional flexibility and growth mindset
  </li>
  <li>
   Change management and strong learning agility
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  <em>
   Preferred Qualifications:
   <br/>
   <br/>
   <br/>
  </em>
 </strong>
 <ul>
  <li>
   Well-developed leadership skills,
  </li>
  <li>
   Negotiation and problem solving skills,
  </li>
  <li>
   Practical knowledge of risk management,
  </li>
  <li>
   Veeva Vault knowledge would be an asset
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What we offer:
  <br/>
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Performance with Choice &ndash; flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.
  </li>
  <li>
   Established job in an international, well-known pharmaceutical company.
  </li>
  <li>
   Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.
  </li>
  <li>
   Opportunity to work within GSK standards and documentation applied globally.
  </li>
  <li>
   Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).
  </li>
  <li>
   Supportive &amp; friendly working environment.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 We&rsquo;re looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference. If this sounds like you, we&rsquo;d love to hear from you!
 <br/>
 <br/>
 As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
 <br/>
 <br/>
 As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
 <br/>
 <br/>
 <strong>
  Why GSK?
  <br/>
  <br/>
 </strong>
 <strong>
  Uniting science, technology and talent to get ahead of disease together.
  <br/>
  <br/>
 </strong>
 GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.
 <br/>
 <br/>
 People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
 <br/>
 <br/>
 GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
 <br/>
 <br/>
 <strong>
  Important notice to Employment businesses/ Agencies
  <br/>
  <br/>
 </strong>
 GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
 <br/>
 <br/>
 Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK&rsquo;s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
 <br/>
 <br/>
</div>


Regulatory Manager Regional Projects CMC

<div><b>Site Name:</b> Poznan Grunwaldzka, Bangalore, Egypt - Cairo<br>
<b>Posted Date:</b> Dec 12 2025<p></p><p><b><br>
Regulatory Project Manager , Regional Projects Team, CMC Excellence</b></p><p></p><p><i>
Within the CMC RA group, the Regional Projects team bring together the operation and execution aspects for key regulatory deliverables for new Directives and Guidelines issued in Regions such as the implementation of eCTD Baselining, general Baselining, Localisation initiatives, and Re- Registrations. The Regional Projects team provide regulatory support across the Regions to deliver Submissions as stipulated in the new HA Directives for pharmaceutical, biopharm and vaccines products.</i></p><p></p><p>
As Regulatory Manager, Regional Projects CMC you will have managerial responsibility for a direct reports as well as accountability and lead for the completion of assigned projects in the CMC Rx and Vx regulatory area. You will work with Head and Manager of Regional Projects as well as with Establish Products Teams to deliver Team&rsquo;s objectives.</p><p></p><p><b><i>
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following&hellip;</i></b></p><p></p><ul><li><p>
Managing people aspects of a team of direct reports to create and sustain an efficient and motivating working environment</p></li><li><p>
Take accountability for tracking, analyzing and reporting of team performance against departmental KPIs</p></li><li><p>
Ensure proper escalation for resource or quality considerations</p></li><li><p>
Independently assess, manage, and/or drive the CMC strategy, coordinate, timely preparation, and author multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the Regional Directives and evolving regulatory requirements.</p></li><li><p>
Understand internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to Localisation projects, and provide guidance to R&amp;D teams, Quality Control, GSC, QA and LOC.</p></li><li><p>
Ensure adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus.</p></li><li><p>
Ensure adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions.</p></li><li><p>
Identify risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.</p></li><li><p>
Contribute to, and lead (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems.</p></li><li><p>
Ensure information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.</p></li><li><p>
Independently manage the completion of data assessment, ensure all appropriate CMC regulatory aspects, serve as dossier approver, identify improvement opportunities, and confidently execute a dossier that is fit for purpose per agreed dossier strategy and timelines.</p></li></ul><p></p><p><b><i>
Why you?</i></b></p><p><b><i>
Basic Qualifications:
</i></b></p><p></p><ul><li><p>Master&rsquo;s degree or higher in a relevant scientific discipline.</p></li><li><p>
Experience in an international regulatory environment or working with multiple markets.</p></li><li><p>
Sound understanding of pharmaceutical industry and regulatory processes with expertise in CMC area</p></li><li><p>
Project Management experience</p></li><li><p>
Capability to build and maintain a team</p></li><li><p>
Fluent English</p></li><li><p>
Strong interpersonal and communication skills</p></li><li><p>
Ability to perform multiple tasks, set the right priorities to deliver objectives on time</p></li><li><p>
Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.</p></li><li><p>
Exceptional flexibility and growth mindset</p></li><li><p>
Change management and strong learning agility</p></li></ul><p></p><p><b><i>
Preferred Qualifications:</i></b></p><ul><li><p>
Well-developed leadership skills,</p></li><li><p>
Negotiation and problem solving skills,</p></li><li><p>
Practical knowledge of risk management,</p></li><li><p>
Veeva Vault knowledge would be an asset</p></li></ul><p></p><p><b>
What we offer:</b></p><ul><li><p>
Performance with Choice &ndash; flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.</p></li><li><p>
Established job in an international, well-known pharmaceutical company.</p></li><li><p>
Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.</p></li><li><p>
Opportunity to work within GSK standards and documentation applied globally.</p></li><li><p>
Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).</p></li><li><p>
Supportive &amp; friendly working environment.</p></li></ul><p></p><p><br>
We&rsquo;re looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference. If this sounds like you, we&rsquo;d love to hear from you!</p><p></p><p><br>
#LI-GSK</p><p>
#LI-HYBRID</p><p></p><p><br>
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.</p><p></p><p>
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
</p><p></p><p><b>Why GSK?</b></p><p><b>
Uniting science, technology and talent to get ahead of disease together.</b></p><p></p><p>
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.</p><p></p><p>
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.</p><p></p><p>
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.</p><p></p><p><b>
Important notice to Employment businesses/ Agencies</b></p><p>
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</p><p></p><p>
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK&rsquo;s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/</p></div>

<div><b>Site Name:</b> Poznan Grunwaldzka, Bangalore, Cairo Boomerang, Warsaw Rzymowskiego 53<br>
<b>Posted Date:</b> Dec 22 2025<p></p><p><b><br>
Regulatory Project Manager, New Registration CMC, CMC Excellence</b></p><p><i>
Within the CMC RA group, the New Registration</i><i> CMC team bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity, product expansion dossiers and CTA submissions. The New Registration</i><i> CMC team provide regulatory support across for development and registration of new pharmaceutical, biopharm and vaccines products.</i></p><p></p><p><b><i><br>
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following&hellip;</i></b></p><ul><li>
Independently assesses, manages, and/or drives the CMC submission deliverables, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for clinical trials, marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements</li><li>
Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to R&amp;D teams, Quality Control, GSC, QA and LOC</li><li>
Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus</li><li>
Ensures adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions</li><li>
Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities</li><li>
Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches</li><li>
Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems</li><li>
Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact</li><li>
Communicates, through the appropriate teams, complex regulatory issues across GSK and with external agencies and third parties as necessary</li><li>
Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines<br>
<br>
<b>What we offer:</b></li><li>
Performance with Choice &ndash; flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.</li><li>
Established job in an international, well-known pharmaceutical company.</li><li>
Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.</li><li>
Opportunity to work within GSK standards and documentation applied globally.</li><li>
Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).</li><li>
Supportive &amp; friendly working environment</li></ul><p></p><p>
#LI-GSK
</p>The annual base salary in Poland for new hires in this position ranges from PLN 183,750 to PLN 306,250 gross, taking into account a number of factors including the candidate&rsquo;s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer&rsquo;s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave &amp; care of family member leave.&amp;#xa;More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.<p></p><p>
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
</p><p></p><p><b>Why GSK?</b></p><p><b>
Uniting science, technology and talent to get ahead of disease together.</b></p><p></p><p>
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.</p><p></p><p>
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.</p><p></p><p>
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.</p><p></p><p><b>
Important notice to Employment businesses/ Agencies</b></p><p>
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</p><p></p><p>
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK&rsquo;s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/</p></div>

Regulatory Project Manager, New Registration CMC

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>

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>

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