Regulatory Affairs Associate

Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
Join Roche, where every voice matters.The PositionA healthier future.
It is what drives us to innovate.
To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That is what makes us Roche.As a Regulatory Affairs Associate, you will efficiently enable ongoing registration of life-changing healthcare solutions (medicines, devices and integrated solutions) for patients in Australia and New Zealand, with a focus on leading submissions and activities that maintain our Licence to Operate The role supports compliance within the Regulatory Strategic Partners Chapter and ensures that supporting processes facilitate continual compliance and risk mitigation.Reporting to the Head of Regulatory Affairs, this role will see you providing a deep knowledge of regulatory operational compliance in the context of our broad product portfolio.
You are driven by the purpose around improving the healthcare ecosystem, both locally and for Roche more broadly.Key responsibilities include:Prepare, submit and manage the approval process of designated regulatory applications to the TGA and MedsafeDevelop and implement optimised regulatory strategies to ensure products remain registered and labels are optimised throughout the lifecycle of the medicine or technology.Develop expertise in local operational processes and systems associated with product information, artwork, planned and ongoing registration activities and other activities as requiredCollaborate with Regulatory Affairs Partners and other cross functional stakeholders to ensure the entire product portfolio remains fully compliant with external and internal requirementsWork with internal stakeholders to develop and optimise new and existing internal processes and systemsProvide regulatory input into pre-market, post market and business activities as requiredAssist with internal and external audits and support records managementWho You AreTertiary qualification in a life sciences field2 or more years' previous experience in a regulatory affairs (preferred) or compliance role in the pharmaceutical, biotechnology, or related industry, within the Australian, New Zealand or other relevant markets is preferred.
Applicants with less experience may be considered on a case by case basisA foundational understanding of the Australian and New Zealand Pharmaceutical regulatory environmentsA strong aptitude and genuine interest in learning, using, and coaching others on complex systems.
Knowledge and expertise in regulatory Veeva-based systems is highly beneficialAdvanced knowledge of Microsoft Office suite: Word, Excel, PowerPoint, and Google suiteKnowledge of the potential utility of AI and a continuous learning mindsetVery good attention-to-detail, interpersonal, communication, analytical and problem-solving skillsGood organisational and time management skillsThis role is only open to candidates that have full eligibility to live and work in Australia.We do not accept any unsolicited resumes or enquiries from recruitment agencies- Roche has a dedicated in-house Talent Acquisition team.What do we offerRoche offers rewarding growth opportunities and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently.
Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders.Roche encourages a high-performance culture where you are empowered and trusted to make decisions.
We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.
Our work gives people more time to be with the ones they love.
Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for Infectious Disease, Cardiovascular Metabolic, Oncology, Neurology, Immunology and Ophthalmology.We care about you - as a whole person.
That's why we place your individual health, and professional growth at the very heart of what we do.
Your well-being is one of our top priority, because when you're thriving, we all succeed.
We offer access to mental health awareness and wellness initiatives that cater to your unique needs - because we understand that well-being is personal.We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community.
We welcome applications from all people and encourage you to advise of any individual circumstances or workplace adjustment that may require consideration.Who we areA healthier future drives us to innovate.
Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come.
Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.
We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let's build a healthier future, together.Roche is an Equal Opportunity Employer.Seniority levelSeniority levelAssociateEmployment typeEmployment typeFull-timeJob functionJob functionQuality Assurance and ConsultingIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment ManufacturingReferrals increase your chances of interviewing at Roche by 2xGet notified about new Regulatory Affairs Associate jobs in Sydney, New South Wales, Australia.Chatswood, New South Wales, Australia 2 weeks agoNorth Ryde, New South Wales, Australia 1 week agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 1 month agoQuality Assurance & Regulatory Affairs AssociateSydney, New South Wales, Australia 5 days agoSydney, New South Wales, Australia 3 days agoSydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 6 days agoSenior Policy Regulatory Affairs OfficerSydney, New South Wales, Australia 2 weeks agoSenior Associate – Global Regulatory Affairs & QualityRegulatory Officer - Registration (Express)Sydney, New South Wales, Australia 2 days agoSydney, New South Wales, Australia 1 day agoManager – Regulatory Affairs and EngagementSydney, New South Wales, Australia 2 weeks agoRegulatory Affairs Manager | Rare Disease | SYDSydney, New South Wales, Australia 6 days agoSenior Manager – Regulatory Affairs and EngagementSydney, New South Wales, Australia 2 weeks agoClinical Research Associate I (MJ000021)Competition, Regulatory & Risk - Senior AssociateSydney, New South Wales, Australia 3 months agoRegulatory Lead - APAC, Kuiper Global Service Compliance External AffairsSydney, New South Wales, Australia 3 days agoHarris Park, New South Wales, Australia 2 weeks agoNorth Sydney, New South Wales, Australia 3 weeks agoLawyer, Senior Associate- Litigation & Regulatory InvestigationsSydney, New South Wales, Australia 2 weeks agoFinancial Regulatory Tax Reporting, Associate 1Sydney, New South Wales, Australia 1 month agoSydney, New South Wales, Australia 1 day agoClinical Research Associate II/Senior - Australia wideSydney, New South Wales, Australia 4 days agoSenior Clinical Research Associate (MJ000012)Clinical Research Associate/Senior Clinical Research AssociateClinical Research Associate II: Bring your career to life at Fortrea
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