Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate (Contract) 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 GSK is looking for a Senior Regulatory Affairs Associate to join the team for a maternity leave contract until end of January 2027. As the Senior Regulatory Affairs Associate, you will help lead regulatory lifecycle activities that keep products licensed, available, and safe for patients in Australia. You will work closely with global teams, local regulatory contacts, quality, medical and commercial partners. We value people who are organised, curious and collaborative. This role offers clear ownership, visible impact on patient access, and strong opportunities to grow your regulatory skills while aligning with GSK’s mission of uniting science, technology and talent to get ahead of disease together. Your role will be varied and will include: Preparing, compiling and delivering high‑quality regulatory submissions and post‑approval documents on time Coordinating cross‑functional inputs for labelling, CMC and dossier content to meet regulatory requirements Maintaining submission trackers, version control and records to keep documentation audit‑ready Preparing timely responses to regulator questions and support meetings with Australian authorities when needed Managing licence maintenance activities such as renewals, variations and site or artwork updates Identifying and implementing process improvements to increase efficiency and submission quality To be successful in this role, you will ideally have: Bachelor’s degree in pharmacy, life sciences, chemistry or a related discipline, or equivalent regulatory experience Minimum 3 years’ experience in regulatory affairs within the pharmaceutical industry Practical experience with product registration, licence maintenance and post‑approval variations Experience preparing dossiers, labelling or CMC documentation to support submissions Strong written and verbal communication skills in English Good organisational skills, attention to detail and ability to manage competing priorities Experience working directly with the Therapeutic Goods Administration (TGA) in Australia Familiarity with electronic submission formats and regulatory information systems Experience with labelling and artwork processes for prescription medicines Postgraduate qualification in a relevant discipline or regulatory affairs training Experience working in a matrix environment with global and local stakeholders By joining GSK, you will enjoy: A flexible and life‑friendly working approach, allowing you to do your best work Career development and progression at a global scale, with international opportunities 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. #J-18808-Ljbffr