Senior Regulatory Specialist

Job description

Business Introduction 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&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. Find out more: Our approach to R&D Position Summary You will lead regulatory CMC activities for Vx products in India. You will manage post-approval variations, site and supply changes, and responses to health authority questions. You will work closely with quality, manufacturing, supply and global regulatory colleagues. We value clear communication, attention to detail and collaborative problem solving. This role offers growth, visible impact on patient access, and the chance to unite science, technology and talent to get ahead of disease together. Responsibilities Independently and confidently executes agreed dossier strategy. Independently manages multiple project simultaneously; assignments will range in complexity but more complex work is expected. Independently completes data assessment to ensure dossier is fit for purpose. Identifies risks associated with submission data and information packages. Escalates issues with line manager that have business impact. Serves as dossier reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems. 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. Understands internal/external regulatory environment. Actively builds an organisational network (GSC, LOC, PO, team members and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing. Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK. Preferred Qualification Minimum 8-10 years of experience Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines Excellent written and verbal communication skills and ability to present information in a clear and concise manner Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience Ability to build effective working relationships and work in a matrix environment effectively Ability to think flexibly in order to meet constantly shifting priorities and timelines. How to apply If this role excites you and you want to grow your regulatory career while making a meaningful impact, we want to hear from you. Please apply and tell us how your experience matches this role. If you need adjustments during the recruitment process, let our recruitment team know so we can support you. Skills Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. 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. 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