Regulatory Affairs Associate

Direct message the job poster from Healthcare Professionals Group

Gemma Louise StaddonClick here to view Gemma Louise Staddon’s profile
Gemma Louise Staddon
Divisional Manager @HPG - Recruiting, Medical Affairs, Regulatory Affairs, Health Economics & Market Access professionals into the Healthcare…
Benefits:
• Competitive salary package
• Collaborative and inclusive work environment
• Opportunity to work from home part of the week

About 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 needed
• Assist in other departmental duties as needed

Skills 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 Sciences

Culture:
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 (gstaddon@hpgconnect.com) for a confidential discussion.