Benefits
• Part-time opportunity offering flexibility
• Work within an established, high-performing regulatory team
• Gain exposure to a global organisation with structured processes
 
About the company
With a strong presence across multiple countries, this organisation is well known for its focus on innovation and high-quality medicines.
 
About the opportunity
This is a part-time opportunity for an experienced Senior Regulatory Affairs professional to support ongoing CMC and lifecycle management activities across a defined product portfolio.
Working closely with the wider regulatory affairs team and broader cross-functional teams, you will focus on maintaining existing registrations. This role suits someone who enjoys detail-oriented regulatory work and can confidently manage submissions and compliance activities in a structured environment.
 
Duties
• Manage regulatory maintenance activities across registered products
• Prepare and submit CMC variations, change notifications and lifecycle updates
• Support submissions to TGA and Medsafe including Category 1 and 3 applications where required
• Ensure compliance with local regulatory requirements and internal SOPs
• Review product information and labelling updates as needed
• Liaise with internal stakeholders to resolve regulatory queries and submission requirements
• Maintain accurate documentation and health authority correspondence records
• Support risk identification and mitigation for regulatory compliance issues
 
Skills and Experience
• Tertiary qualification in Pharmacy or Life Sciences
• Demonstrated experience in Regulatory Affairs within pharma/biotech
• Strong experience in CMC and lifecycle management activities
• Solid understanding of TGA and Medsafe requirements
• Experience preparing and managing regulatory submissions and variations
• Strong attention to detail and ability to manage multiple priorities
• Confident working cross-functionally and communicating with stakeholders
 
Culture
A collaborative and structured environment with a strong focus on quality and compliance. The team values reliability, accountability and a practical approach to getting regulatory work done efficiently.
 
How to Apply
Ready to take the next step? Click apply or contact Gemma Staddon on +61 2 8877 8776 for a confidential discussion.
 
About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.
• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.