regulatory specialist

University of Vermont

<div><div><div><div>Position Details
</div><p></p><div><div><div><div><b>Advertising/Posting Title</b></div> <div>Regulatory Specialist</div>
</div><br>
<div><div><b>Posting Summary</b></div>
<div>Provide support for the regulatory aspects of clinical trial participation at the University of Vermont Cancer Center. Prepare and track regulatory documentation. Provide guidance and subject matter expertise to other members of the research team for regulatory and compliance aspects of conducting clinical research. Maintain documentation in compliance with federal and local regulations, and distribute materials to local and affiliate sites.</div>
</div><br>
<div><div><b>Minimum Qualifications (or equivalent combination of education and experience)</b></div>
<div>Bachelor&rsquo;s degree and one to three years related experience with or demonstrated ability to learn federal regulations and guidelines required. Ability to make independent decisions in a fast-paced, regulated environment required. Ability to work collaboratively with investigators, staff, and regulators required. Effective written and verbal communication skills and editorial skills required.</div>
</div><br>
<div><div><b>Desirable Qualifications</b></div>
<div>Experience at an academic research organization, research certification (e.g., CCRP, RAC), familiarity with Click software, and experience related to oncology clinical trials desirable.</div>
</div><br>
<div><div><b>Anticipated Pay Range</b></div> <div>$24.50-$27.00/hr</div>
</div><br>
<div><div><b>Other Information</b></div>
</div><br>
<div></div><div><div><b>Special Conditions</b></div> <div>Bargaining unit position, External candidates must complete a 4-month probationary period, A probationary period may be required for current UVM employees, This position is eligible for a hybrid schedule with an option to split time between campus and elsewhere, in accordance with the university telecommuting policy, Background Check required for this position, A probationary period may be required</div>
</div><br>
<div><div><b>FLSA</b></div> <div>Non-Exempt</div>
</div><br>
<div><div><b>Union Position</b></div> <div>Yes, UVMSU</div>
</div><br>
</div></div></div><div><div>Posting Details
<p>Position will be posted for a minimum of one week, after which it is subject to removal without notice.</p>
</div><div><div><div><div><b>Job Location</b></div> <div>Burlington, Vermont, United States</div>
</div><br>
<div><div><b>Job Open Date</b></div> <div>10/06/2025</div>
</div><br>
<div><div><b>Job Close Date (Jobs close at 11:59 PM EST.)</b></div>
</div><br>
<div></div><div><div><b>Open Until Filled</b></div> <div>No</div>
</div><br>
</div></div></div><div><div>Our Common Ground Statement
<p>The University of Vermont is a welcoming, educationally purposeful community committed to creating an inclusive environment that embraces intellectual diversity and global perspectives. We seek to prepare students to be accountable leaders who will bring to their work a grasp of complexity, effective problem-solving and communication skills, and an enduring commitment to learning and ethical conduct. Members of the University of Vermont community embrace and advance the values of Our Common Ground: Respect, Integrity, Innovation, Openness, Justice, and Responsibility. Staff play a critical role in this effort and the successful candidate will demonstrate a strong commitment to UVM&rsquo;s mission and advancing Our Common Ground values through the execution of their job duties.</p>
</div></div><div></div><div><div>Position Information
</div><p></p><div><div><div><div><b>Position Title</b></div> <div>Research Data Analysis OC2 N</div>
</div><br>
<div><div><b>Posting Number</b></div> <div>S5771PO</div>
</div><br>
<div><div><b>Department</b></div> <div>Vermont Cancer Center/55060</div>
</div><br>
<div><div><b>Position Number </b></div><div>012279</div>
</div><br>
<div><div><b>Percent of Full-Time</b></div> <div>1.0</div>
</div><br>
<div><div><b>Standard Hours at 1.0 FTE</b></div> <div>37.5</div>
</div><br>
<div><div><b>Term (months per year)</b></div> <div>12</div></div></div></div></div></div></div><p></p>

Regulatory Specialist

<div><p>Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization? If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.
</p><p></p><p>As Regulatory Operations Manager, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.
</p><p></p><p>This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following&hellip;
</p><ul><li>Fulfil standard, ad hoc, or complex data reporting request and design outputs.
</li><li>Assist Regulatory Business Operations (RBO) staff in delivery of projects.
</li><li>Assist RBO staff in process documentation, monitoring, and reporting.
</li><li>Maintain Team sites.
</li><li>Adhere to records retention.
</li><li>Complete appropriate training.
</li><li>Assist Regulatory Business Operations staff to optimize project plan robustness (scope, deliverables, resources, timing).
</li><li>Provide project support to meet assigned business deliverables.
</li><li>Edit existing process documentation and lead monitoring and reporting.
</li><li>Provide analysis and interpretation of information in response to requests from requestors and pursue greater data quality through identification of gaps and delivery of efficient solutions.
</li></ul><p></p><p><b><i>Why you?
</i></b></p><p></p><p>Basic Qualifications:
</p><p></p><p>We are looking for professionals with these required skills to achieve our goals:
</p><ul><li>Bachelor&rsquo;s degree.
</li><li>3 years of pharmaceutical industry experience in a regulatory environment.
</li><li>Experience with License Maintenance as well as overall R&amp;D processes.
</li><li>Direct experience with project planning &amp; execution.
</li></ul><p></p><p>Preferred Qualifications:
</p><p></p><p>If you have the following characteristics, it would be a plus:
</p><ul><li>Master&rsquo;s degree or MBA
</li><li>Experience working in a matrixed environment
</li><li>Demonstrated ability to engage and influence senior stakeholders.
</li></ul><p></p><p><b><i>Why GSK?
</i></b></p><p></p><p><i>Our values and expectations are at the heart of everything we do and form an important part of our culture.
</i></p><p><i>These include </i><i>Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. </i><i>As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
</i></p><ul><li>Operating at pace and agile decision-making &ndash; using evidence and applying judgement to balance pace, rigour and risk.
</li><li>Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
</li><li>Continuously looking for opportunities to learn, build skills and share learning.
</li><li>Sustaining energy and well-being.
</li><li>Building strong relationships and collaboration, honest and open conversations.
</li><li>Budgeting and cost-consciousness.
</li></ul><p></p><p><b><i>*This is a job description to aide in the job posting, but does not include all job evaluation details.
</i></b></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><b>Inclusion at GSK:
</b></p><p>As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
</p><p></p><p>Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
</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>It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
</p><p></p><p><b>GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
</b></p><p></p><p>If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in &ldquo;gsk.com&rdquo;, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.</p></div><p></p>

<div><b>Site Name:</b> Poznan Grunwaldzka, Cairo Boomerang, Warsaw<br>
<b>Posted Date:</b> Oct 20 2025<p></p><p><b><br>
Regulatory Specialist, CMC Renewals</b></p><p></p><p>
Renewals CMC Team (Chemistry, Manufacturing, and Controls) plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our main area we are also working with technology to perform at our best as we operate in a fast-paced and evolving environment.</p><p></p><p><b>
Key Responsibilities:</b></p><ul><li><p>
Manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency;</p></li><li><p>
Defines and agrees on regulatory strategy, completes data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements for international markets;</p></li><li><p>
Identifies risks associated with submission data and information packages;</p></li><li><p>
Escalates issues with line manager that have business impact, suggesting possible solutions;</p></li><li><p>
Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications.;Identifies improvement opportunities for regulatory processes, policies and systems;</p></li><li><p>
Effectively communicates also in a digital context, including virtual meetings and digital platforms;</p></li><li><p>
Works with colleagues in Global Manufacturing &amp; Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;</p></li><li><p>
Understands internal/external regulatory environment;</p></li><li><p>
Monitors regulatory intelligence and acts proactively on identified changes to regulatory requirements;</p></li><li><p>
Supports digital transformation through active participation in building digital skills.</p></li></ul><p></p><p><b><i>
Why You?</i></b></p><p><b>
Basic qualifications:</b></p><ul><li><p><b>
Min. bachelor's degree</b> in Life Sciences, Chemistry, Health Sciences, or related fields;</p></li><li><p><b>
1-2 years of relevant experience</b> in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation is required);</p></li><li><p>
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes;</p></li><li><p><b>
Excellent written and verbal English language communication</b> skills and ability to present information to diverse colleagues in global locations in a clear and concise manner;</p></li><li><p><b>
Mindset that embraces digital transformation and innovation</b> through adaptability, forward-thinking, and exploring new possibilities in the ever-evolving digital landscape;</p></li><li><p><b>
Good team worker, ready to lead initiatives</b> when needed;</p></li><li><p>
Excellent interpersonal skills; <b>communication and influencing skills</b> with the ability to work in a diverse environment and build relationships across a large organization;</p></li><li><p><b>
Excellent time management skills</b> to handle multiple assignments, prioritize and schedule work to meet business needs;</p></li><li><p><b>
Detail-oriented, with emphasis on accuracy, completeness and consistency;</b></p></li><li><p>
Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes;</p></li><li><p>
Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts;</p></li><li><p>
Veeva Vault knowledge would be an asset.</p></li></ul><p></p><p><b><i>
Why GSK?</i></b></p><p>
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.</p><ul><li><p>
Career at one of the leading global healthcare companies;</p></li><li><p>
Contract of employment;</p></li><li><p>
Attractive reward package (annual bonus &amp; awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit);</p></li><li><p>
Life insurance and pension plan;</p></li><li><p>
Private medical package with additional preventive healthcare services for employees and their eligible;</p></li><li><p>
Sports cards (Multisport);</p></li><li><p>
Possibilities of development within the role and company&rsquo;s structure;</p></li><li><p>
Personalized learning approach (mentoring, online training&rsquo; platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training);</p></li><li><p>
Extensive support of work life balance (flexible working solutions, short Fridays option, health &amp; well-being activities);</p></li><li><p>
Supportive community and integration events;</p></li><li><p>
Modern office with creative rooms, fresh fruits everyday;</p></li><li><p>
Free car and bike parking, locker rooms and showers.</p></li></ul><p></p><p>
We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team <b>(</b><b>pl.recruitment-adjustments@gsk.com</b><b>) </b>to further discuss this today.</p><p></p><p>
#LI-GSK #LI-Hybrid</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 special purpose &ndash; to unite science, technology and talent to get ahead of disease together &ndash; so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns &ndash; as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).</p><p></p><p>
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it&rsquo;s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves &ndash; feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.</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 Specialist, CMC Renewals

<div><b>Site Name:</b> Poznan Grunwaldzka, Cairo Boomerang, Warsaw<br>
<b>Posted Date:</b> Oct 20 2025<p></p><p><b><br>
Senior Regulatory Specialist, CMC Renewals</b></p><p></p><p>
Renewals CMC Team (Chemistry, Manufacturing, and Controls) plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our main area we are also working with technology to perform at our best as we operate in a fast-paced and evolving environment.</p><p></p><p><b>
Key Responsibilities:</b></p><ul><li><p>
Independently manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency; assignments will range in complexity but more complex work is expected;</p></li><li><p>
Independently and confidently defines and agrees on regulatory strategy, completes data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements for international markets;</p></li><li><p>
Identifies risks associated with submission data and information packages;</p></li><li><p>
Escalates issues with line manager that have business impact, suggesting possible solutions;</p></li><li><p>
Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications;</p></li><li><p>
Identifies improvement opportunities for regulatory processes, policies and systems;</p></li><li><p>
Serves as dossier reviewer (peer review and/or quality check);</p></li><li><p>
Provides consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff;</p></li><li><p>
Effectively communicates also in a digital context, including virtual meetings and digital platforms;</p></li><li><p>
Works with colleagues in Global Manufacturing &amp; Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;</p></li><li><p>
Understands internal/external regulatory environment;</p></li><li><p>
Monitors regulatory intelligence and acts proactively on identified changes to regulatory requirements;</p></li><li><p>
Supports digital transformation through active participation in building digital skills.</p></li></ul><p></p><p><b><i>
Why You?</i></b></p><p><b>
Basic qualifications:</b></p><ul><li><p><b>
Min. bachelor's degree</b> in Life Sciences, Chemistry, Health Sciences, or related fields;</p></li><li><p><b>
Min. 3 years of relevant experience</b> in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation is required);</p></li><li><p>
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes;</p></li><li><p><b>
Excellent written and verbal English language communication</b> skills and ability to present information to diverse colleagues in global locations in a clear and concise manner;</p></li><li><p><b>
Mindset that embraces digital transformation and innovation</b> through adaptability, forward-thinking, and exploring new possibilities in the ever-evolving digital landscape;</p></li><li><p><b>
Good team worker, ready to lead initiatives</b> when needed (project management skills would be an asset);</p></li><li><p>
Excellent interpersonal skills; <b>communication and influencing skills</b> with the ability to work in a diverse environment and build relationships across a large organization;</p></li><li><p><b>
Excellent time management skills</b> to handle multiple assignments, prioritize and schedule work to meet business needs;</p></li><li><p><b>
Detail-oriented, with emphasis on accuracy, completeness and consistency;</b></p></li><li><p>
Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes;</p></li><li><p>
Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts;</p></li><li><p>
Veeva Vault knowledge would be an asset.</p></li></ul><p></p><p><b><i>
Why GSK?</i></b></p><p>
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.</p><ul><li><p>
Career at one of the leading global healthcare companies;</p></li><li><p>
Contract of employment;</p></li><li><p>
Attractive reward package (annual bonus &amp; awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit);</p></li><li><p>
Life insurance and pension plan;</p></li><li><p>
Private medical package with additional preventive healthcare services for employees and their eligible;</p></li><li><p>
Sports cards (Multisport);</p></li><li><p>
Possibilities of development within the role and company&rsquo;s structure;</p></li><li><p>
Personalized learning approach (mentoring, online training&rsquo; platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training);</p></li><li><p>
Extensive support of work life balance (flexible working solutions, short Fridays option, health &amp; well-being activities);</p></li><li><p>
Supportive community and integration events;</p></li><li><p>
Modern office with creative rooms, fresh fruits everyday;</p></li><li><p>
Free car and bike parking, locker rooms and showers.</p></li></ul><p></p><p>
We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team <b>(</b><b>pl.recruitment-adjustments@gsk.com</b><b>) </b>to further discuss this today.</p><p></p><p>
#LI-GSK #LI-Hybrid</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 special purpose &ndash; to unite science, technology and talent to get ahead of disease together &ndash; so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns &ndash; as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).</p><p></p><p>
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it&rsquo;s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves &ndash; feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.</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>

Senior Regulatory Specialist, CMC Renewals

<div>
 <strong>
  Site Name:
 </strong>
 Poznan Grunwaldzka, Cairo Boomerang, Warsaw
 <br/>
 <br/>
 <strong>
  Posted Date:
 </strong>
 Oct 20 2025
 <br/>
 <br/>
 <strong>
  Senior Regulatory Specialist, CMC Renewals
  <br/>
  <br/>
 </strong>
 Renewals CMC Team (Chemistry, Manufacturing, and Controls) plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our main area we are also working with technology to perform at our best as we operate in a fast-paced and evolving environment.
 <br/>
 <br/>
 <strong>
  Key Responsibilities:
  <br/>
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Independently manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency; assignments will range in complexity but more complex work is expected;
  </li>
  <li>
   Independently and confidently defines and agrees on regulatory strategy, completes data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements for international markets;
  </li>
  <li>
   Identifies risks associated with submission data and information packages;
  </li>
  <li>
   Escalates issues with line manager that have business impact, suggesting possible solutions;
  </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;
  </li>
  <li>
   Identifies improvement opportunities for regulatory processes, policies and systems;
  </li>
  <li>
   Serves as dossier reviewer (peer review and/or quality check);
  </li>
  <li>
   Provides consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff;
  </li>
  <li>
   Effectively communicates also in a digital context, including virtual meetings and digital platforms;
  </li>
  <li>
   Works with colleagues in Global Manufacturing &amp; Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;
  </li>
  <li>
   Understands internal/external regulatory environment;
  </li>
  <li>
   Monitors regulatory intelligence and acts proactively on identified changes to regulatory requirements;
  </li>
  <li>
   Supports digital transformation through active participation in building digital skills.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  <strong>
   Why You?
   <br/>
   <br/>
  </strong>
 </em>
 <strong>
  Basic qualifications:
  <br/>
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Min. bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields;
  </li>
  <li>
   Min. 3 years of relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation is required);
  </li>
  <li>
   Understanding of the pharmaceutical industry, drug development environment, and regulatory processes;
  </li>
  <li>
   Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner;
  </li>
  <li>
   Mindset that embraces digital transformation and innovation through adaptability, forward-thinking, and exploring new possibilities in the ever-evolving digital landscape;
  </li>
  <li>
   Good team worker, ready to lead initiatives when needed (project management skills would be an asset);
  </li>
  <li>
   Excellent interpersonal skills; communication and influencing skills with the ability to work in a diverse environment and build relationships across a large organization;
  </li>
  <li>
   Excellent time management skills to handle multiple assignments, prioritize and schedule work to meet business needs;
  </li>
  <li>
   Detail-oriented, with emphasis on accuracy, completeness and consistency;
  </li>
  <li>
   Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes;
  </li>
  <li>
   Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts;
  </li>
  <li>
   Veeva Vault knowledge would be an asset.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  <strong>
   Why GSK?
   <br/>
   <br/>
  </strong>
 </em>
 Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Career at one of the leading global healthcare companies;
  </li>
  <li>
   Contract of employment;
  </li>
  <li>
   Attractive reward package (annual bonus &amp; awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit);
  </li>
  <li>
   Life insurance and pension plan;
  </li>
  <li>
   Private medical package with additional preventive healthcare services for employees and their eligible;
  </li>
  <li>
   Sports cards (Multisport);
  </li>
  <li>
   Possibilities of development within the role and company&rsquo;s structure;
  </li>
  <li>
   Personalized learning approach (mentoring, online training&rsquo; platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training);
  </li>
  <li>
   Extensive support of work life balance (flexible working solutions, short Fridays option, health &amp; well-being activities);
  </li>
  <li>
   Supportive community and integration events;
  </li>
  <li>
   Modern office with creative rooms, fresh fruits everyday;
  </li>
  <li>
   Free car and bike parking, locker rooms and showers.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team
 <strong>
  (
 </strong>
 <strong>
  pl.recruitment-adjustments@gsk.com
 </strong>
 <strong>
  )
 </strong>
 to further discuss this today.
 <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 special purpose &ndash; to unite science, technology and talent to get ahead of disease together &ndash; so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns &ndash; as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
 <br/>
 <br/>
 Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it&rsquo;s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves &ndash; feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
 <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>


Givaudan

<p>Join us and celebrate the beauty of human experience. Create for happier healthier lives with love for nature. Together with passion and creativity we deliver food innovations craft inspired fragrances and develop beauty and wellbeing solutions. Theres much to learn and many to learn from with more than 16000 employees around the world to explore ideas and ambitions with. Every day your talent your innovative spirit and your determination will shape our future making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature.</p><p><b>Junior Regulatory Specialist SAMEA Regulatory Taste & Wellbeing - Your future role</b></p><p>As a Junior Regulatory Specialist in Dubai you will provide basic regulatory support to internal and external customers in the GCC/Middle East to ensure compliance with legal requirements and corporate guidelines. Typically works under the supervision and guidance of senior peers.</p><p>You will report to the respective Regulatory Manager.</p><p>This is an open contract role working 5 days a week. Your monthly payroll will be processed by a 3rd party partner.</p><p><b>Your main responsibilities:</b></p><ul><li><p>Provide internal customers (sales operations or other regulatory teams) and external customers with consistent and compliant formula reviews and documentation in a timely manner to meet commercial and customer requirements.</p></li><li><p>Completion of customer product and quality questionnaires</p></li><li><p>Maintain and manage request logs and use functionalities of internal SAP-based regulatory systems and databases.</p></li><li><p>Implement routine processes and procedures.</p></li><li><p>Support the commercialization of products by working with commercial teams as directed.</p></li><li><p>Assist regulatory specialists and managers with assigned tasks and projects.</p></li><li><p>Participate in and contribute to regulatory projects as needed.</p></li></ul><p><b>You have:</b></p><ul><li><p>Bachelors degree in a scientific discipline (e.g. Food Science Food Technology Chemistry)</p></li><li><p>1-2 years of relevant regulatory experience in the food industry or a related sector ideally within the GCC region.</p></li><li><p>Strong PC skills including competency in MS Office products.</p></li><li><p>Business fluency in English and Arabic Language.</p></li><li><p>Strong Knowledge in food chemistry or related disciplines.</p></li><li><p>Working knowledge of industry and regulatory requirements in GCC/Middle East region.</p></li><li><p>Basic understanding of components of appropriate business processes and internal systems</p></li><li><p>Basic knowledge of regulatory systems.</p></li></ul><p>At Givaudan you contribute to delightful taste and scent experiences that touch peoples lives.<br>You work within an inspiring teamwork culture where you can thrive collaborate and learn from other talented and passionate people across disciplines regions and divisions.<br>Every essence of you enriches our world.<br>Diversity drives innovation and creates closer connections with our employees customers and partners.<br>Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world.<br></p><br><p><b>Required Experience:</b></p><p>Junior IC</p><img src="https://www.jobg8.com/Tracking.aspx?FXIqvVuqFNguGBQgJMew0jd%2fgXECaM09f" width="0" height="0" />

Job Opportunities Junior Food Regulatory Specialist

Vivandi

<p><b>Industry:</b> Haircare | Hair loss | Supplements | Nutrition | FMCG</p><p><b>Position Summary:</b></p><p>The Regulatory Specialist will be responsible for managing and ensuring compliance with all applicable regulatory requirements in the <b>United Arab Emirates (UAE)</b> and <b>Kingdom of Saudi Arabia (KSA)</b>. The role involves handling product registration, documentation, labeling, and regulatory approvals for <b>Haircare, Hair loss, Nutrition, Supplements, and FMCG</b> products. The incumbent will work closely with internal departments and regulatory authorities to facilitate smooth market entry and continuous compliance.</p><p><b>Key Responsibilities:</b></p><ul><li>Manage and oversee the <b>product registration process</b> with relevant regulatory authorities such as <b>Dubai Municipality (DM)</b>, <b>Emirates Authority for Standardization and Metrology (ESMA)</b>, <b>Ministry of Health and Prevention (MOHAP)</b>, <b>Saudi Food and Drug Authority (SFDA)</b>, <b>Saudi Standards, Metrology and Quality Organization (SASO)</b>, and <b>Gulf Standardization Organization (GSO)</b>.</li><li>Prepare, compile, and maintain regulatory dossiers and technical documentation for new and existing products.</li><li>Ensure all product formulations, claims, and ingredients comply with <b>UAE and KSA</b> regulations.</li><li>Review and approve product <b>labels, artworks, and promotional materials</b> for regulatory compliance.</li><li>Coordinate with internal teams including <b>Research &amp; Development (R&amp;D)</b>, <b>Quality Assurance</b>, <b>Marketing</b>, and <b>Supply Chain</b> to ensure timely submission and maintenance of documentation.</li><li>Monitor and interpret <b>regulatory updates, standards, and guidelines</b> issued by UAE and Saudi authorities, advising management on necessary actions.</li><li>Support import clearance processes and ensure all compliance documentation is accurate and up to date.</li><li>Maintain a database of registered products, licenses, and renewal timelines to ensure continuous market authorization.</li><li>Provide regulatory guidance during <b>new product development (NPD)</b> and reformulation projects.</li><li>Ensure compliance with <b>Good Manufacturing Practices (GMP)</b>, <b>Gulf Cooperation Council (GCC)</b>, and <b>Halal certification</b> requirements applicable to the product categories.</li><li>Liaise with consultants, distributors, and third-party agencies involved in the regulatory process across both markets.</li></ul><p><b>Qualifications and Experience:</b></p><ul><li><b>Bachelor&rsquo;s Degree</b> in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.</li><li>Minimum <b>3&ndash;5 years of experience</b> in Regulatory Affairs within the <b>Haircare, Nutrition, Supplements, or FMCG</b> industries.</li><li>Comprehensive knowledge of <b>UAE and KSA regulatory systems</b>, procedures, and documentation requirements.</li><li>Proven experience in <b>product registration, labeling compliance</b>, and <b>import documentation</b> for cosmetics, personal care, or nutritional products.</li><li>Strong understanding of <b>SFDA</b>, <b>DM</b>, <b>ESMA</b>, <b>SASO</b>, and <b>GSO</b> frameworks and processes.</li><li>Excellent communication and coordination skills with government authorities and internal stakeholders.</li><li>High attention to detail, strong organizational skills, and the ability to manage multiple projects simultaneously.</li><li>Proficiency in <b>English &amp; Arabic</b> is mandatory.</li></ul><p><b>Key Competencies:</b></p><ul><li>Regulatory Documentation and Dossier Management</li><li>Analytical and Problem-Solving Skills</li><li>Strategic and Proactive Regulatory Planning</li><li>Stakeholder Management</li><li>Compliance and Risk Awareness</li><li>Adaptability and Process Orientation</li></ul><p>Job Type: Full-time</p><p>Pay: AED6,000.00 - AED8,000.00 per month</p>

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