Regulatory Lead - VMS

Regulatory Lead- VMS

• Location: Virginia, Brisbane (Sydney also considered)
• Hybrid working and Flexible environment

About the job

Are you looking to take your Regulatory expertise and passion for Complimentary Medicine innovation to the next level? The Regulatory Lead- VMS will play an integral part in our Science Team, where you will ensure all the projects adhere to best in class regulatory and risk minimisation plans. Using your knowledge of the ANZ Therapeutic, dietary supplements or food product regulations to support the registrations and submissions, claim assessments, approvals, continued compliance and monitoring of the wider environment to plan and execute processes. Working closely with multiple key stakeholders and functions within the business at a local and regional level- from Quality, Brand Marketing, Supply Chain, R&D and external departments to drive business objectives and priorities.

At Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.  

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. 

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Telfast, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.  

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. 

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. 

Join us on our mission. Health. In your hands.

Main responsibilities:

• Ensure project team plans include 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

• Develop and maintain excellent relationships with health authorities to effectively negotiate timely approvals and optimal product labelling and risk minimisation strategies

• Monitor regulatory environment to identify potential future changes and ensure impact to business is communicated to relevant local and regional contacts. With particular regard to Complementary Medicines and Evidence for Listed Medicines (AU) and Dietary Supplements Regulations (NZ)

• Ensure continued regulatory compliance through maintenance of applications by timely submission of post-approval variations and active discontinuation of unused applications with no portfolio value

• Support for maintaining regulatory departmental systems in line with new developments in regulatory affairs and ensuring any required revisions to departmental systems and processes are implemented

• Preparation and submission of regulatory documentation and applications for registered or listed complementary medicines, including compliance review of relevant quality and regulatory documents against relevant legislation

• Assessment of claim summary documents from Medical Scientific Affairs team to establish validity of required claims to meet regulatory and advertising code regulations

• Assessment of 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

• Understand the key requirements of the Australian and NZ therapeutic, dietary supplements and food products regulatory systems and assist communication of interpretation of regulations and guidelines to key stakeholders within the business

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

• Proven ability to build and maintain excellent relationships with health authorities

• Experience in guiding and preparing submissions