
Regulatory Expert
3 days ago
Job Overview
We are seeking a highly skilled Regulatory Specialist to join our Science Team. As a key member of the team, you will be responsible for ensuring that all projects adhere to best-in-class regulatory and risk minimisation plans.
In this role, you will use your knowledge of ANZ Therapeutic, dietary supplements or food product regulations to support registrations and submissions, claim assessments, approvals, continued compliance and monitoring of the wider environment to plan and execute processes.
You will work closely with multiple key stakeholders and functions within the business at a local and regional level to drive business objectives and priorities.
About Us
Our company is committed to making self-care simple by being consumer-led always, with science at our core.
We deliver our mission: helping more than half a billion consumers worldwide take their health in their hands through our unique and balanced portfolio of more than 100 loved brands.
Main Responsibilities
- Develop and implement optimal regulatory and risk minimisation strategies through collaboration with key local and global stakeholders to provide cross-functional expertise and drive on-time submission and approvals in accordance with agreed business priorities.
- Establish and maintain excellent relationships with health authorities to effectively negotiate timely approvals and optimal product labelling and risk minimisation strategies.
- Monitor the regulatory environment to identify potential future changes and ensure impact to business is communicated to relevant local and regional contacts.
- Maintain regulatory departmental systems in line with new developments in regulatory affairs and ensure any required revisions to departmental systems and processes are implemented.
- Evaluate claim summary documents from Medical Scientific Affairs team to establish validity of required claims to meet regulatory and advertising code regulations.
- Evaluate product artwork and promotional material to ensure compliance with relevant regulations within CHC risk profile guidelines and promotional policy.
- Ensure continuity of supply through maintenance of ARTG submissions, and compliance to Food or cosmetic code requirements, by timely submission of updates as applicable.
About You
Experience:
- Proven experience and understanding of key requirements for Complimentary Medicines.
- The Australian and NZ Therapeutic, dietary supplements and food products regulatory systems.
- Ability to build and maintain excellent relationships with health authorities.
Soft and Technical Skills:
- Excellent communication skills to collaborate with multiple functions internally and build partnerships with external stakeholders.
- A hands-on approach and leadership capabilities.
- Ability to engage, simplify and communicate scientific information to various audiences.
Qualifications:
- University Degree in Science-related discipline, Therapeutic, and complimentary medicine certification or Regulatory Science preferred.
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