Regulatory Lead- VMS Innovation

Location: Virginia, Brisbane

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 Innovation 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 Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

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 of regulatory documents and applications for relevant complimentary medicines

Soft and Technical Skills:

• Excellent communication skills to collaborate with multiple functions internally and build partnerships with external stakeholders

• 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

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Play an impactful part in creating best practices as we continue to break boundaries in innovation and best in class manufacturing practices

• Join a high performing, friendly and supportive team environment, where collaboration and teamwork is key to success

• Multi-national organisation of globally loved Consumer Healthcare brands, boasting a portfolio of local and global OTC and VMS (multivitamin and supplement) products

• Beautiful Brisbane based offices in sunny Queensland, where you will have be onsite our manufacturing facilities and see where all the magic comes to life!

• Highly innovative, purpose driven organisation where we think outside the box

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)