Senior Regulatory Affairs Associate
PharmaBiotechRegulatory AffairsQuality Assuranceregulatory submissionemacro
Job description
About GSK GSK is a global biopharma company with a special purpose: to unite science, technology and talent to get ahead of disease together. Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be, where they can continue to grow and look after their wellbeing. If you share our ambition, join us at this exciting moment in our journey to get Ahead Together. About the role We are seeking a Senior Regulatory Affairs Associate to join our Vaccines Regulatory Affairs team based in our Abbotsford office, Melbourne . Supporting a diverse vaccines portfolio across Australia and New Zealand, you'll work on new product registrations, new indications and lifecycle management activities while partnering with local and global stakeholders to help bring innovative vaccines to patients. This role offers broad exposure across the product lifecycle, from supporting regulatory strategies for pipeline assets through to maintaining an established portfolio. With a strong pipeline and opportunities to work on future vaccine innovations, this is an excellent opportunity to further develop your regulatory career within a global organisation. Your role will be varied and will include: Leading regulatory submissions for new products, new indications and lifecycle activities Managing designated products and acting as the local regulatory lead Developing regulatory strategies and responding to health authority questions Partnering with local and global stakeholders to deliver regulatory and business objectives About you We are looking for a collaborative and proactive regulatory professional who enjoys working across complex projects and building strong stakeholder relationships. You will have a strong background in pharmaceutical Regulatory Affairs and a passion for supporting patient access to innovative medicines and vaccines. Experience in both new registrations and lifecycle management is highly valued, however we welcome applications from professionals who are looking to broaden their experience across the full product lifecycle. You will need: A science-based degree or postgraduate qualification in a relevant discipline At least 3 years' experience in Regulatory Affairs within the pharmaceutical industry Experience supporting new product registrations and/or lifecycle management activities Strong communication , stakeholder management and organisational skills Why join us? At GSK, we challenge ourselves to get Ahead Together, to make a positive impact on global health, drive innovation and create an environment where our people can thrive. Our culture inspires performance, development and growth. By joining GSK, you'll enjoy: A flexible and life-friendly working approach, allowing you to do your best work Being part of a diverse organisation that reflects the communities we serve Development and progression opportunities on a global scale 5 Feel Good Days and 1 Volunteer Day each year The option to purchase up to 4 weeks' additional leave per year Access to discounted health insurance Certified Great Place To Work® May 2026-May 2027 * LI-GSK Skills Digital Fluency, Pharmaceutical Regulatory Affairs, Problem Solving, Regulatory Affairs Management, Regulatory Strategies 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. We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com . Please note this email is for a
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Mechanical Assembler
Thermo Fisher Scientific — Eindhoven, Netherlands
CRA (Level II)
Thermo Fisher Scientific — 2 Locations
Application Scientist
Thermo Fisher Scientific — Shanghai, China
Biostatistician II
Thermo Fisher Scientific — Beijing, China
Sr Project Mgr
Thermo Fisher Scientific — Beijing, China
Programmer Analyst
Thermo Fisher Scientific — Guangdong, China