Sr Regulatory Affairs Associate

Senior Regulatory Affairs Associate
Clinical, Medical, Regulatory
Sydney, Australia
Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing career

Your new role
As a Senior Regulatory Affairs Associate, you will:

• Lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist product development, registration, and commercialisation.
• Manage the preparation, compilation, and timely submission of accurate regulatory documentation for new product registrations, variations, renewals, and responses to queries.
• Serve as the primary liaison with regulatory authorities, maintaining positive relationships while monitoring and conveying developments in the regulatory landscape.
• Collaborate with cross-functional teams and stakeholders to provide regulatory guidance throughout the product lifecycle, represent regulatory affairs in decision-making processes, and assist with commercialisation.
• Maintain accurate regulatory records for assigned products in Regulatory Information Management (RIM) platforms, participate in audits to ensure compliance with regulatory standards, and contribute to updating and implementation of Standard Operating Procedures (SOPs) as needed.

Your new department
You will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Senior Regulatory Affairs Manager. Our department is focused on leading regulatory affairs activities for new products and product amendments, We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety and efficacy of our products. The atmosphere is collaborative and dynamic, with a strong focus on professional development and continuous improvement.

Your Skills & Qualifications

• Bachelor's degree in a scientific discipline or a related field.
• A minimum of 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry, with significant expertise in Australian regulatory requirements.
• Demonstrated proficiency in leading regulatory affairs strategies, preparation and submission of regulatory documentation, regulatory affairs intelligence and the development and approval of product labelling.
• Strong competency in stakeholder management, comprehensive business and industry knowledge, adaptability in dynamic environments, effective execution, and impactful communication.
• Must either be an Australian Citizen or Permanent Resident.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What We Offer
In addition to being part of a collaborative and authentic culture, our employees are rewarded with Health and Wellbeing days, gifted leave between Christmas and New Year, extensive learning and development opportunities and regular team and company offsite events. Our field staff have the latest technology in a laptop, tablet and mobile phones with a very competitive car allowance.

Deadline
Until the completion of recruitment. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.