Job Title: Regulatory Affairs Associate
About the Role:
The Regulatory Affairs Associate plays a critical role in ensuring 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:
This 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. Regulatory Monitoring and Updates: Monitor and interpret Australian and New Zealand regulatory requirements and guidelines for pharmaceutical, medical device, and other healthcare products, providing timely updates to internal stakeholders on relevant changes impacting product registrations and compliance.
2. Submission Coordination: Coordinate and compile necessary documentation for regulatory submissions, ensuring accuracy, completeness, and timeliness.
3. Submission Execution: Submit regulatory submissions, including product registrations, variations, renewals, and responses to regulatory requests.
4. Cross-Functional Collaboration: Collaborate with cross-functional teams to provide regulatory guidance and support for product development, labeling, and marketing activities.
5. Regulatory Record Management: Assist in maintaining regulatory records across Regulatory Information Management (RIM) platforms for assigned product portfolio, ensuring compliance with local and global procedures and accurate up-to-date information.
6. Document Preparation: Prepare and maintain regulatory documentation, including prescribing information, packaging materials, and instructions for use, in compliance with applicable regulations.
7. Stakeholder Engagement: Act as a liaison with regulatory authorities, fostering positive relationships and representing the company's interests during meetings.
8. Audit Participation: Participate in internal and external audits to ensure compliance with regulatory requirements and quality management systems.
9. Commercialisation Support: Support the commercialisation of products through participation in local brand teams.
10. Project Assignments: Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager/Sr Manager.
11. Reporting: Report any adverse event within 24 hours as per AbbVie's policies and procedures.
12. WHS Commitment: Proactively participate in AbbVie's WHS programs, adhere to policies, and promote a safe work environment at all times.
13. Compliance Adherence: Adhere to AbbVie's internal codes of conduct and compliance processes.
14. Additional Responsibilities: Perform other ad hoc duties such as administrative tasks, as requested.