regulatory manager

<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>

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

Jelly Belly Candy Company

<div><div><b>SUMMARY</b></div>
<div></div><div>Responsible for compliant packaging information, which includes but is not limited to: ingredient statements, nutrition panels, signature line, net weight and marketing claims. Packaging compliance includes US, Canada, EU, AU and other markets as needed. Oversee product formula review for market compliance. Oversee ingredient and vendor approval program. Oversee and participate in product formula generation, review and distribution. Write and maintain training material for Regulatory procedures. Fully participate in Optiva software development and insure appropriate training materials are prepared and maintained.</div>
<div></div><div><b>ESSENTIAL DUTIES AND RESPONSIBILITIES </b>may include the any or all of the following.</div>
<div></div><div>Oversee the completion and integration of Regulatory Compliance Projects.</div>
<div></div><div>Oversees and participates in the Supplier Approval Program.</div>
<div></div><div>Oversees and participates in packaging review, domestic and international.</div>
<div></div><div>Oversee and sign-off on the development of formulas for production needs, Excel and Word formats.</div>
<div></div><div>Oversees and sign-off on the creation of ingredient statements and nutrition panels for both domestic and international markets.</div>
<div></div><div>Oversees, participates and sign off in customer/consumer/supplier inquiries.</div>
<div></div><div>Oversee, insure accuracy and sign off on customer requested forms, documents.</div>
<div></div><div>Prepare acceptance and next step guidelines for work sent to outside laboratories both routine and custom projects.</div>
<div></div><div>Keep current on changing regulatory landscape for ingredients, additives, and packaging regulations.</div>
<div></div><div>Participates in updating the HACCP plan.</div>
<div></div><div>Participates in plant audits.</div>
<div></div><div>Oversee the maintenance of the ingredient statements, nutrition panel library, and finished-good product specifications.<br>
</div><div>Inherent in each position is a general duty to maintain each respective work area in a safe and sanitary condition. Regular, predictable, full-time attendance is required as an essential function of this position. The employee may be required to perform other such duties within the scope of their employment as may be assigned. The employee must also possess the ability to take direction, follow instructions, work with others, follow work rules and schedules, and focus on details.</div>
<div></div><div><div><b>SUPERVISORY RESPONSIBILITIES </b>Direct supervisory responsibilities for Regulatory Compliance Supervisor and Technicians.</div>
<div></div><div><b>QUALIFICATIONS </b>To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</div>
<div></div><div><b>EDUCATION and/or EXPERIENCE </b>Bachelor&rsquo;s Degree in Food Science, Biology or Physical Science preferred. 3-5 years work experience in a food packaging compliance. Supervisorial experience preferred.</div>
<div></div><div>**All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.**</div></div></div>

Regulatory Compliance Manager

<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

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

Global Regulatory Affairs Manager (homebased)

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.
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 <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.
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  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
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 </strong>
 <strong>
  Qualifications:
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  <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>


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