Regulatory Affairs Associate

Regulatory Affairs Associate | ANZ page is loaded

Regulatory Affairs Associate | ANZApply locations Sydney time type Full time posted on Posted 2 Days Ago time left to apply End Date: September 7, days left to apply) job requisition id

At 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 Position

A 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 purposearound improvingthehealthcare 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 Medsafe.

• Develop 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 required.

• Collaborate with Regulatory Affairs Partners and other cross functional stakeholders to ensure the entire product portfolio remains fully compliant with external and internal requirements.

• Work with internal stakeholders to develop and optimise new and existing internal processes and systems.

• Provide regulatory input into pre-market, post market and business activities as required.

• Assist with internal and external audits and support records management.

Who you are

• Tertiary qualification in a life sciences field.

• 2 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 basis.

• A foundational understanding of the Australian and New Zealand Pharmaceutical regulatory environments.

• A strong aptitude and genuine interest in learning, using, and coaching others on complex systems. Knowledge and expertise in regulatory Veeva-based systems is highly beneficial.

• Advanced knowledge of Microsoft Office suite: Word, Excel, PowerPoint, and Google suite

• Knowledge of the potential utility of AI and a continuous learning mindset.

• Very good attention-to-detail, interpersonal, communication, analytical and problem-solving skills.

• Good organisational and time management skills.

This 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 offer

Roche 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 impactsto our employees, customers and the community. We welcome applications from all people and encourageyou to advise of any individual circumstances or workplace adjustment that may require consideration.

Who we are

A 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.

About Us

We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

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