Regulatory Affairs

Regulatory Affairs Associate

• Sydney
• Competitive Salary Package

Benefits: • Work for a leading pharmaceutical organisation • Collaborative and inclusive work environment • Flexible working arrangements – WFH & office About the Company: Join a globally recognised pharmaceutical organisation with a strong commitment to delivering innovative therapies and improving patient outcomes. About the Opportunity: Join a high-performing regulatory team as a Regulatory Affairs Associate on a 12-month contract with potential for extension. Reporting to an experienced and supportive Regulatory Manager, you will contribute to key regulatory initiatives and collaborate with internal stakeholders. This position offers the chance to work within a team known for its technical expertise and commitment to professional growth. Duties • Lead preparation and submission of CAT 1 and CAT 3 applications. • Collaborate with internal teams to respond to TGA queries and ensure compliance. • Manage chemistry and clinical documentation with a hands-on approach. • Contribute to cross-functional projects, taking on additional responsibilities as needed. Skills and Experience • Proven expertise in CAT 1 regulatory submissions and TGA processes. • 2-3 years of experience with prescription medicine submissions in Australia • Demonstrated ability to manage submissions independently • Self-sufficient and adaptable, able to handle complex tasks without extensive training. • Team-oriented mindset with the ability to collaborate and grow within the role. • Comprehensive understanding of TGA regulations and requirements • Bachelor’s degree in Life Sciences or a related field Culture: Join a team that values diversity, inclusivity, and professional growth. The organization fosters a supportive culture where employees are empowered to take ownership of their work and contribute meaningfully to shared goals. How to Apply: Click "Apply" or contact Gemma Staddon at gstaddon@hpgconnect.com.