Regulatory Affairs Professional

2 weeks ago

North Sydney Council, Australia Novo Nordisk AS Full time

We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Novo Nordisk A/S. This role offers an exciting opportunity for individuals passionate about regulatory affairs to play a key role in ensuring the availability of life-changing medicines.

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. Your responsibilities will include:

  • Preparing, compiling, and timely submitting accurate regulatory documentation for new product registrations, variations, renewals, and responses to queries;
  • Serving as the primary liaison with regulatory authorities, maintaining positive relationships while monitoring and conveying developments in the regulatory landscape;
  • Collaborating 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;
  • Maintaining accurate regulatory records for assigned products in Regulatory Information Management (RIM) platforms, participating in audits to ensure compliance with regulatory standards, and contributing to updating and implementation of Standard Operating Procedures (SOPs) as needed.

To be successful in this role, you will require a Bachelor's degree in a scientific discipline or a related field, along with a minimum of 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry, specifically in Australian regulatory requirements. You should possess demonstrated proficiency in leading regulatory affairs strategies, preparation and submission of regulatory documentation, regulatory affairs intelligence, and the development and approval of product labelling.

In addition to your technical expertise, you will need to have strong competency in stakeholder management, comprehensive business and industry knowledge, adaptability in dynamic environments, effective execution, and impactful communication. As we work closely with health authorities and policymakers to shape future regulatory frameworks, you will be required to maintain a high level of professionalism and confidentiality.

The estimated salary for this position is around $120,000 - $150,000 AUD per annum, depending on qualifications and experience. If you are an Australian Citizen or Permanent Resident with a passion for regulatory affairs and a commitment to excellence, we invite you to apply for this rewarding opportunity.

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