Regulatory Affairs Jobs at GSK
Explore an exciting career opportunity in the regulatory field with a globally recognized leader in healthcare innovation. This Senior Regulatory Affairs Associate role in Abbotsford, Australia, offers life science professionals a chance to contribute to impactful regulatory activities supporting product quality, safety, and patient access. Ideal for those seeking Regulatory Affairs jobs, this position provides a dynamic environment, global collaboration, and career growth within one of the world’s most respected biopharma organizations.
About the Company
GSK is a global biopharmaceutical leader committed to positively impacting the health of 2.5 billion people over the next decade. With a strong focus on vaccines, medicines, and cutting-edge technology, GSK fosters an ambitious, collaborative culture focused on doing the right thing for patients. Through innovation and global expertise, GSK empowers employees to grow professionally while contributing to life-changing scientific advancements.
Job Details
- Job Title: Senior Regulatory Affairs Associate (Contract)
- Location: Abbotsford, Australia
- Department: Regulatory
- Job ID: 432023
- Contract duration: Until end of January 2027
Job Overview
GSK is seeking a Senior Regulatory Affairs Associate to support regulatory lifecycle management and ensure products remain licensed, available, and safe for patients in Australia. The role involves cross-functional collaboration with global regulatory teams, quality, medical, and commercial partners. This position offers strong ownership, high visibility, and opportunities for professional growth.
Key Responsibilities in Regulatory Affairs Jobs
- Prepare, compile, and deliver high-quality regulatory submissions and post-approval documentation.
- Coordinate cross-functional inputs for labelling, CMC, and dossier content.
- Maintain submission trackers, version control, and audit-ready records.
- Prepare responses to regulatory authority questions and support TGA meetings where needed.
- Manage licence maintenance activities, including renewals, variations, and artwork or site updates.
- Identify and implement process improvements to enhance efficiency and submission quality.
Qualifications & Experience
Required:
- Bachelor’s degree in life sciences, or related field (or equivalent experience).
- Minimum 3 years of regulatory affairs experience in the pharmaceutical industry.
- Hands-on experience with product registration, lifecycle management, and post-approval variations.
- Experience preparing dossiers, labelling, or CMC documentation.
- Strong written and verbal communication skills in English.
- Excellent organisation, attention to detail, and ability to manage multiple priorities.
- Experience working with the Therapeutic Goods Administration (TGA).
- Familiarity with electronic submissions and regulatory information systems.
- Experience with prescription medicine labelling and artwork processes.
- Experience collaborating in matrix environments with global and local teams.
Preferred:
- Postgraduate qualification in a relevant field.
- Formal regulatory affairs training.
What GSK Offers in Regulatory Affairs Jobs
- Flexible, life-friendly working arrangements.
- Global career development and progression opportunities.
- A mission-driven environment dedicated to improving global health.
