Regulatory Affairs Associate (12 Month Contract)
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Job no: 496371
Work type: Full Time/Fixed Term
Location: Victoria
Categories: Science and Regulatory
A bit about us
If you are looking for a fantastic team and a challenging, fast, and dynamic work environment, you are at the right place!
On our journey to making a positive difference across the world, you will work with passionate people in an innovative and collaborative organization as we inspire wellness through #PurposeLedCareers
We are dedicated to our customers, community, and environment and are looking for similar-minded talent to join us! As an equal opportunity employer, we care deeply about creating an inclusive workplace where our team members feel valued, respected, and empowered.
Our total rewards package offering includes additional annual leave, bonuses, wellness programs, health benefits, flexible and remote working arrangements, and performance awards - not to mention various social and recreational activities, all of which are regional specific.
With over 3,400 team members working across the globe, our vision is focused on premium nutrition and lifetime wellness, backed by science. We have 3 business segments - Baby, Adult and Pet Nutrition and Care - supporting whole - family health and happiness across 7 international brands.
The variety of work creates unlimited opportunities to excel across a breadth of disciplines; you will be presented with a wealth of new pathways and opportunities to explore throughout your career. Working with us will be more than just a job; we guarantee a life-changing experience as you step into an environment that moves quickly and presents new challenges daily.
Your role within the team
As a Regulatory Affairs Associate, you’ll play a key role in delivering our regulatory strategy and supporting business goals across Australia and New Zealand. You’ll help ensure compliance across a diverse product portfolio, working throughout the entire product lifecycle—from concept and development to in-market activities. While your primary focus will be on TGA-listed complementary medicines, you’ll also gain exposure to an exciting mix of products including foods, dietary supplements, infant formula, skincare, and pet supplements. This is a fantastic opportunity to contribute to the development and continuous improvement of regulatory frameworks and risk management processes in a dynamic, fast-paced environment. This role is a parental leave cover and will be a 12 month contract.
Key responsibilities include:
- Support overall regulatory compliance of therapeutic and non-therapeutic products in Australia and New Zealand
- Support the Regulatory team operations (including but not limited to):
- Supporting the development and maintenance of product dossiers
- Support regulatory reviews of product formulations for compliance against various domestic and international regulations, relevant codes of practice and market requirements
- Review product labelling for regulatory compliance and maintain relevant records
- Administer advertising pre-vetting and approvals, including reviewing of promotional material for regulatory and technical compliance
- Contribute to the development, implementation and maintenance of regulatory SOPs, procedures and data management to ensure due diligence and sponsor obligations are met
- Work cross functionally, providing technical and regulatory advice across internal teams, including but not limited to Customer Service, Quality, NPD, Operations, Sales, Customer Service, Digital and Marketing teams
- Support business initiatives related to relevant government bodies / agencies, such as the TGA, FSANZ, Medsafe, AICIS, APVMA etc.
- Support product related complaints issued by regulatory bodies
- Support the QPPVA in managing safety-related (Pharmacovigilance) reports, internal processing and analysis and TGA/Medsafe reporting, as required
- Keep up to date with domestic and international regulatory considerations and changes
- Assist with team projects and reporting
Desired Skills & Experience
We look for people who have what it takes to make an impact; who can challenge us to go further while pushing themselves to deliver exciting & ambitious results.
To make sure we’re setting new starters up for success, we ask that you meet a few criteria relevant to the role to be considered for this opportunity:
- >2 years of Regulatory Affairs experience with complementary medicines, foods, cosmetics, baby nutrition and/or pet nutrition.
- Tertiary qualifications in Medical, Health, or Life Sciences
- Sound knowledge of Australian and New Zealand regulatory requirements for therapeutic (AUST L complementary medicines) and/or non-therapeutic products (foods, skincare, baby nutrition and pet nutrition)
- International regulatory experience is considered advantageous.
- Solutions-focused mindset with a proactive approach.
- Has a commercial focus and understanding relating to regulatory decisions with the ability to think outside the box
- Has experienced working in a fast-paced commercial environment and can think on their feet
- Has supported multiple projects with competing timelines, all at once
- Strong collaborative approach and positive, team-oriented mindset.
- Ability to support risk assessments and provide risk based regulatory advice to the business
- Appreciates legal issues relating to product marketing and advertising
H&H Group believes in the benefits of a diverse & inclusive workplace & aims to reflect the varied cultures within which we exist. We are committed to providing a working environment that is free from discrimination & harassment, creating a safe and inclusive environment for all.
We encourage applications from people of all ages, nationalities, religions, racial and gender identities, sexual orientations, abilities and cultures, & our hiring decisions will be based on business needs, position requirements, & the qualifications and experience of individuals. If you require support or assistance during the application process, please notify us at the time of application and we will be sure to enable reasonable adjustments where suitable.
If you have what it takes, please apply via the online portal & we will be in touch soon. We move quickly & may fill the role prior to the application close date, so we suggest you get in touch today!
Advertised: AUS Eastern Daylight Time
Applications close: AUS Eastern Daylight Time
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