Senior Regulatory Specialist, Established Products Global Labelling, LSG

<p></p><p></p><p><br/><br/>At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&amp;D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.</p><p><br/>Find out more:<br/><a href="https://www.gsk.com/en-gb/innovation/" rel="noopener noreferrer" target="_blank">Our approach to R&amp;D</a><br/><br/><b>Senior Regulatory Specialist, Established Products Global Labelling, LSG</b><br/><br/>This role offers an exciting opportunity to contribute to global regulatory labelling activities for established products. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and deliver high-quality labelling documents. We value candidates who are detail-oriented, proactive, and passionate about making a meaningful impact in healthcare. Join us to grow your career and help us achieve our mission of uniting science, technology, and talent to get ahead of disease together.<br/><br/><b>Responsibilities</b><br/>This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:</p><ul><li><p><span><span>Maintain and update the Company Core Datasheet / Global Datasheet (CCDS/GDS), EU PI (CP/MRP/DCP), and Medical Device product labels.</span></span></p></li><li><p><span><span>Lead the discussion at Labelling Review Team (LRT) around the proposed wording for the CCDS/GDS and centrally managed PIs and seek agreement with all stakeholders involved.</span></span></p></li><li><p><span><span>Support the Local Operating Companies (LOC) in, i.e.,  the implementation of Global PI text into country PI, and authoring and coordinating responses to labelling questions from regulatory agencies.</span></span></p></li><li><p><span><span>Take accountability for relevant labelling sections of the periodic aggregate reports.</span></span></p></li><li><p><span><span>Represent Global Labelling in the Regulatory Matrix Team (RMT), the Safety Review Team (SRT) and Product Investigation Review Committee (PIRC) and internal audits.</span></span></p></li><li><p><span><span>You may represent GSK Global Labelling in inspections or meetings with regulatory authorities and external events <span>(conferences/seminars,</span> etc.)</span></span></p></li></ul><p></p><p></p><p><b>Basic Qualification</b></p><p>We are seeking professionals with the following required skills and qualifications to help us achieve our goals:</p><p></p><ul><li><p>Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.</p></li><li><p>Experience in in pharmaceutical industry, life sciences research or regulatory.</p></li><li><p>Understanding of the pharmaceutical industry, drug development environment and regulatory processes.</p></li><li><p>Excellent English written and verbal communication skills.</p></li><li><p>Detail-oriented with strong organizational and time management skills.</p></li><li><p>Ability to work independently and collaboratively in a fast-paced environment.</p></li></ul><p><br/><b>Preferred Qualification</b></p><ul><li><p>Master’s or PhD degree in a relevant field.</p></li><li><p>Preferred experience in labelling or regulatory affairs. </p></li><li><p>Proven ability to adapt to changing priorities and provide innovative solutions.</p></li><li><p>Knowledge of Polish language is a plus.</p></li><li><p>Experience with digital tools and platforms used in regulatory labelling.</p></li></ul><p></p><p><b>Why GSK?</b></p><p>At GSK we offer a wide range of additional benefits: </p><ul><li><p>Career at one of the leading global healthcare companies</p></li><li><p>Hybrid work ( 2/3 days per week from the office)</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’s structure</p></li><li><p>Personalized learning approach.</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 eve