Benefits
- Broad ANZ regulatory scope across medicines and medical devices
- Collaborative, quality-driven environment with real influence
- Flexible working environment with a mix of office and WFH, supported by a collaborative team
About the company
This is a global healthcare organisation with an established presence across Australia and New Zealand. The business manages a sizeable and diverse portfolio and operates with a lean local team, offering individuals strong visibility and meaningful responsibility.
About the opportunity
An experienced Senior Technical and Regulatory Associate is being appointed to support continued portfolio management and future growth. Reporting to the Regional Head, you'll take ownership of a defined portfolio and manage it day to day with a high level of autonomy.
Duties
- Support the Regional Head in managing departmental priorities
- Prepare and maintain product and technical files across the portfolio
- Manage new product registrations, variations and export registrations
- Manage and liaise with local and international contract manufacturers
- Review and approve promotional materials and product labellingDevelop and maintain compliant claims support
- Provide technical and regulatory guidance to internal stakeholders
Skills and Experience
- Bachelor of Science, Pharmacy or related scientific qualification
- Demonstrated experience in Technical, Regulatory roles within OTC pharma and/or Medical Device
- Strong working knowledge of TGA requirements and GMP
- Medical device regulatory experience required
- Confident reviewing advertising and labelling in a regulated environment
- Comfortable working autonomously while being a genuine team player
- Clear communicator who enjoys collaborating cross-functionally
Culture
You'll be joining a pragmatic, high-trust team where expertise is valued and accountability matters.
Regulatory Affairs Associate employer: Healthcare Professionals Group
Join a leading Australian business in the therapeutic goods sector, where you will play a pivotal role as a Regulatory and Quality Manager. This position offers a collaborative work culture that values innovation and continuous improvement, providing ample opportunities for professional growth and development. With a focus on shaping compliance frameworks and engaging with both local and international suppliers, you'll find a rewarding environment that encourages meaningful contributions to the healthcare landscape.
Contact Details:
Healthcare Professionals Group Recruitment Team
