General role description

Regulatory Affairs Specialists ensure that health and medical products meet all applicable regulatory standards throughout their lifecycle.

They play a key role in compiling and submitting documentation to regulatory authorities, maintaining compliance with local and international legislation, and supporting cross-functional teams involved in product development, manufacturing, labelling, marketing, and post-market surveillance.

These professionals help organisations bring safe, effective, and high-quality products - such as pharmaceuticals, medical devices, biologics, and diagnostics - to market.

Key responsibilities

• Prepare, compile, and submit regulatory dossiers and applications to regulatory authorities (e.g. TGA, FDA, EMA)
• Monitor changes in local and global regulations and interpret their impact on products
• Ensure compliance across pre-market and post-market product stages
• Provide regulatory guidance to internal teams (e.g. R&D, clinical, marketing, manufacturing)
• Review product labelling, advertising, and promotional materials for regulatory compliance
• Liaise with regulatory bodies and respond to queries or requests for information
• Maintain up-to-date knowledge of regulatory requirements and standards
• Develop or maintain internal SOPs and quality documentation related to regulatory affairs.