Registration Executive

<p><br /><b><span>Registration Executive, Regulatory Affairs Department</span></b> <b>(Maternity Leave position for 12 months)</b><br /><br />The Regulatory Affairs team ensures compliance, efficient registration,  and license to operate of pharmaceutical products, vaccines  in Ukraine, supporting company operations and quality standards.</p><p></p><p>The Registration Executive manages regulatory processes for product registration, renewals, and variations, while ensuring compliance with regulations and GSK standards. The role involves collaboration with internal teams and regulatory institutions to support product registration and support maintenance of the Quality Management System (QMS).<br /> </p><p><span class="emphasis"><b>Key Responsibilities:</b></span></p><ul><li>Prepare, submit, update, and manage registration dossiers for pharmaceutical products and vaccines.</li><li>Handle of post-registration activities such as variations, and renewals for pharmaceutical products and vaccines</li><li>Collaborate with logistics and supply teams to coordinate registration activities timelines</li><li>Establish and maintain relationships with regulatory institutions; handle pre-registration analyses.</li><li>Ensure proper archiving, document updates, and compliance with GSK and local standards.</li><li>Prepare and submit documentation for GMP compliance confirmation in Ukraine.</li><li>Timely update of the internal regulatory systems in accordance with GSK standards and requirements</li></ul><p><br /><b><span class="emphasis">Basic Qualifications:</span></b></p><ul><li>University degree (Master/Magister preferred).</li><li>At least 1 year of experience in a related field.</li><li>Fluency in English, both written and oral.</li><li>Strong communication skills.</li><li>Knowledge of Ukrainian legislation on registration/re-registration of medicinal products and GMP compliance.</li></ul><p>#LI-GSK<br />G8</p><p></p><p><b>Why GSK?<br />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 – 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’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>Contact information:</b><br />You may apply for this position online by selecting the <b>Apply now</b> button.</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&#39;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>