The opportunity
We are seeking a highly skilled and experienced Senior Regulatory Affairs Associate to join our regulatory affairs team.
In this role, you will prepare and execute regulatory submission plans and implement the agreed regulatory strategy to register and maintain products across a range of therapeutic areas, covering both Australia and New Zealand.
This role requires strong attention to detail, excellent communication skills, and a deep understanding of regulatory guidelines and processes within the pharmaceutical industry.
How you’ll spend your day
• Prepare and submit regulatory dossiers to health authorities for new product approvals and maintenance variations.
• Ensure compliance with all relevant regulations, guidelines, and company policies.
• Monitor and analyse regulatory changes and trends to ensure company compliance.
• Assist in the development and implementation of regulatory strategies for new and existing products.
• Maintain up-to-date knowledge of global regulatory requirements and ensure that company practices align with these standards.
• Review and approve labelling, promotional materials, and other product-related documentation for regulatory compliance.
