Access to ongoing professional development and growth opportunities
About the Company
Join a leading global healthcare company dedicated to enhancing the well-being of people in Australia and New Zealand through the development and marketing of a diverse portfolio.
About the Opportunity
As a Senior Regulatory Affairs Associate, you will play a pivotal role leading the regulatory strategy and execution for the consumer health portfolio. You will provide strategic regulatory direction to the ANZ Leadership Team, ensuring the appropriate regulatory approvals and product marketing authorizations are obtained. This is a unique opportunity to shape the local regulatory environment and have a significant impact on the product portfolio's success. Flexibility to work from home and in the office.
Duties
Provide strategic regulatory direction to the ANZ Leadership Team
Lead and manage the entire regulatory operations to obtain timely approvals
Define regulatory priorities and guide the Global RA team
Ensure compliance with existing product licenses and regulatory requirements
Review and approve promotional and non-promotional materials
Maintain regulatory files and databases, including GMP records
Develop and implement regulatory SOPs and processes
Keep abreast of relevant regulatory and industry activities
Liaise with external stakeholders and support audits and post-market activities
Foster cross-functional working relationships and represent the company in relevant committees
Skills and Experience
Bachelor's Degree in Life Sciences
Experience working in regulatory affairs, ideally in Consumer Health
Experience in leading end-to-end new product registrations
Strong knowledge of regulatory aspects in Australia and New Zealand
Culture
Our client appreciates the unique contributions of every team member, and their workplace fosters professionalism, cooperation, and a welcoming atmosphere, providing an ideal setting for personal and professional growth.
How to Apply
Click apply or contact Gemma Staddon on 02 8877 8776 or Erin Cox on 02 8877 8734 for a confidential discussion.