Regulatory Affairs Specialist - Contract (BBBH36586) Northern Beaches, Australia
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Benefits
Flexible working arrangement; combined office and WFH role
Friendly and collaborative work culture
Work with a broad range of established consumer healthcare brands
About the company
A multinational consumer healthcare organisation with around 60 staff in Australia. They boast a wide range of proprietary brands and continue to grow their market share in Australia as they focus on introducing new and innovative products to the consumer.
About the opportunity
You will join the newly created New Products & Brand Development team tasked with bringing proprietary brands to the Australian market. The position requires demonstrated Regulatory Affairs knowledge for New Production Innovation in both Australia and New Zealand. The portfolio will include consumer healthcare products, low class medical devices, complementary medicines, and FMCG products.
Duties
- Develop and implement regulatory strategy for the new product portfolio.
- Develop and maintain regulatory-driven launch times for the innovation pipeline.
- Regulatory planning, submissions, and application to relevant Government authorities and regulatory bodies
- Maintain regulatory compliance for all NPD products.
- Review and approval of packaging and label claims
- Ensure products specs, safety, and stability data are compliant with local regulations.
- Ensure product compliance in line with TGA, Medsafe, AICIS, Poison Standard guidelines.
Skills and Experience
- Degree qualified in chemistry, pharmaceutical science, or similar
- Minimum 5 years’ regulatory affairs experience working with TGA guidelines
- Must have demonstrated experience working with listed and regulated therapeutic goods in Australia.
- Ability to work collaboratively with the cross-functional team to ensure project objectives are met
- Proven problem solver with high attention to detail
- Excellent communication skills and confident to present to management and regulatory agencies
- The ideal candidate will be a well-organized, articulate, self-starter, and a team player.
Culture
Fast-paced, collaborative, and enjoyable working environment. Support work/life balance and promote responsible working.
How to Apply
Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.