Regulatory Affairs Associate

Benefits:• Competitive salary package• Collaborative and inclusive work environment• Opportunity to work from home part of the weekAbout the Company:Join a leading pharmaceutical organisation with a rich history in developing life-changing medications.About the Opportunity:Embark on a 12-month contract as a Regulatory Affairs Associate. This role primarily involves managing product manufacturing site change activities, including TGA liaison and internal stakeholder coordination. You will assist with various regulatory duties as needed. Reporting to an experienced leader in the field, you will work within a dynamic and supportive team.Duties:• Manage the sponsorship transfer of oncology asset• Handle labelling, artwork, and CAT 3 submissions• Oversee product manufacturing site change activities• Liaise with TGA and internal stakeholders• Conduct GMP clearances• Assist in other departmental duties as neededSkills and Experience:• Experience completing submissions with prescription medicines in Australia• Able to complete submissions independently• Evidence of success in managing CAT 3, CMC for small molecules and biologics• Familiarity with TGA regulations• Bachelor's degree in Life SciencesCulture:Inclusive and supportive culture - our client believes in empowering their employees to make informed decisions and providing a supportive environment for professional growth.How to Apply:Click "Apply" or contact Gemma Staddon (******) for a confidential discussion.
#J-18808-Ljbffr