Job Description
The Regulatory Affairs Associate ensures compliance with regulatory guidelines and requirements for the development, registration, and maintenance of pharmaceutical, medical device, and other healthcare products in Australia and New Zealand. Working with our Aesthetics business, the associate will work closely with internal departments, regulatory authorities, and external stakeholders to support product registration, submissions, and ongoing regulatory compliance activities.
KEY DUTIES AND RESPONSIBILITIES
1. 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.
2. Coordinate and compile necessary documentation for regulatory submissions, ensuring accuracy, completeness, and timeliness.
3. Submit regulatory submissions, including product registrations, variations, renewals, and responses to regulatory requests.
4. Collaborate with cross-functional teams to provide regulatory guidance and support for product development, labeling, and marketing activities.
5. 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.
6. Prepare and maintain regulatory documentation, including prescribing information, packaging materials, and instructions for use, in compliance with applicable regulations.
7. Act as a liaison with regulatory authorities, fostering positive relationships and representing the company's interests during meetings.
8. Participate in internal and external audits to ensure compliance with regulatory requirements and quality management systems.
9. Support the commercialisation of products through participation in local brand teams.
10. Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager/Sr Manager.
11. Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
12. Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
13. Adhere to AbbVie’s internal codes of conduct and compliance processes.
14. Other ad hoc duties such as administrative duties, as requested.
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