AbbVie is seeking a knowledgeable and detail-oriented Regulatory Affairs Associate for a 12 month, Max Term Contract opportunity based in North Sydney, relocating to the Sydney CBD in Q4 2026. The position provides support  for the full spectrum of regulatory activities across Australia and New Zealand, including preparing and submitting product registrations, variations, and renewals, maintaining accurate regulatory records across RIM platforms, and collaborating with cross-functional teams to provide expert regulatory guidance across product development, labeling, and marketing activities.

You will bring a strong understanding of Australian and New Zealand regulatory requirements, excellent communication and relationship-building skills, and the ability to act as a credible liaison with regulatory authorities, while thriving in a fast-paced environment and contributing to AbbVie's commitment to compliance and commercial success.

KEY DUTIES AND RESPONSIBILTIES

• Monitor and interpret Australian and New Zealand regulatory requirements and guidelines for pharmaceutical, medical device, and other healthcare products and update internal stakeholders on relevant changes impacting product registrations and compliance.
• Coordinate and compile necessary documentation for regulatory submissions, ensuring accuracy, completeness, and timeliness.
• Submit regulatory submissions, including product registrations, variations, renewals, and responses to regulatory requests.
• Collaborate with cross-functional teams to provide regulatory guidance and support for product development, labeling, and marketing activities.
• Assist in maintaining regulatory records across Regulatory Information Management (RIM) platforms for assigned product portfolio in compliance with local and global procedures to ensure accurate and up-to-date information.
• Prepare and maintain regulatory documentation, including prescribing information, packaging materials, and instructions for use, in compliance with applicable regulations.
• Act as a liaison with regulatory authorities, fostering positive relationships and representing the company's interests during meetings.
• Participate in internal and external audits to ensure compliance with regulatory requirements and quality management systems.
• Support the commercialisation of products through participation in local brand teams
• Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager
• Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
• Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties, as requested.