Senior Regulatory Specialist

<p>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.</p><p>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.</p><p>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.</p><p>We’re uniting science, technology, and talent to get ahead of disease together.<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></p><p><br/><b>Position Summary:</b><br/>This role is an exciting opportunity to make a meaningful impact in Regulatory Affairs of biopharmaceutical asset/s. As a Senior Regulatory Specialist, you will play a key role in delivering regulatory submissions and ensuring compliance with evolving global standards. You’ll collaborate with cross-functional teams and a wide range of stakeholders from all over the world to deliver high-quality CMC dossiers.</p><p><br/><b>Basic Qualification</b></p><p>We are seeking professionals with the following required skills and qualifications to help us achieve our goals:</p><ul><li>Independently and confidently executes agreed dossier strategy.</li><li>Minimum of 3 years of experience in CMC</li><li>Bachelor’s degree in Chemistry, pharmacy or other related science or technical bachelor’s degree.</li><li>Independently manages multiple BioPharm project assignments simultaneously; assignments will range in complexity, but more complex work is expected.</li><li>Independently completes data assessment to ensure dossier is fit for purpose.</li><li>Identifies risks associated with submission data and information packages.</li><li>Escalates issues with line manager that have business impact.</li><li>May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.</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. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff. </li><li>Understands internal/external Regulatory environment.</li><li>Actively builds an organizational network (GSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.</li><li>Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK</li></ul><p></p><p><b>Preferred Qualification</b><br/>If you have the following characteristics, it would be a plus:</p><ul><li>Broad understanding of the pharmaceutical industry, drug development environment, and R&amp;D processes and objectives.</li><li>Global Regulatory submission experience - Knowledge of regulatory agency guidelines</li><li>Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines</li><li>Excellent written and verbal communication skills and ability to present information in a clear and concise manner</li><li>Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience</li><li>Ability to build effective working relationships and work in a matrix environment effectively</li><li>Ability to think flexibly in order to meet constantly shifting priorities and timelines</li></ul><p></p><p><b>Work Environment</b><br/>Hybrid work ( 2/3 days per week from the office)</p><p><br/>We encourage you to apply and bring your unique skills and experiences to GSK. Together, we can make a difference in global healthcare.</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 <a href="mailto:pl.recruitment-adjustments@gsk.com" rel="noopener noreferrer" target="_blank"><span>pl.recruitment-adjustments@gsk.com</span></a> to discuss your needs.</p><p></p><p></p><p>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.</p><p>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.</p><p>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 pr