Senior Regulatory Affairs Associate at GSK

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

11 Mar, 26

Salary

0.0

Posted On

11 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Pharmaceutical Industry, Product Registration, Licence Maintenance, Post-Approval Variations, Dossier Preparation, Labelling, CMC Documentation, Communication Skills, Organisational Skills, Attention to Detail, TGA Experience, Electronic Submission Formats, Artwork Processes, Matrix Environment, Collaboration

Industry

Pharmaceutical Manufacturing

Description

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 Senior Regulatory Affairs Associate (Contract) 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 *LI-GSK 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Responsibilities

The Senior Regulatory Affairs Associate will lead regulatory lifecycle activities to ensure products are licensed, available, and safe for patients in Australia. Responsibilities include preparing regulatory submissions, coordinating cross-functional inputs, and managing licence maintenance activities.