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Regulatory Affairs Specialist
\This role involves supporting regulatory processes for products in Australia and New Zealand, ensuring compliance while promoting development and registration.
\Your Key Responsibilities\- Support regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while assisting developing strategies to facilitate product development, registration, and commercialisation.
- Manage the preparation, compilation, and timely submission of accurate regulatory documentation for product registrations, variations, renewals, and responses to queries.
- Liaise with regulatory authorities, maintaining positive relationships while monitoring and conveying developments in the regulatory landscape.
- Support collaboration 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.
You will be part of a team focused on leading regulatory affairs activities for new products and product amendments. The team works 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. Based in Sydney, you'll join a team that values innovation, teamwork, and making a meaningful impact on patients' lives.
\Requirements\- Bachelor's degree in a scientific discipline or a related field.
- A minimum of 2 years of experience in regulatory affairs within the pharmaceutical industry.
- Knowledge of Australian regulatory requirements.
- Demonstrated proficiency in supporting the preparation and submission of regulatory documentation, as well as the development and approval of product labeling.
- Must either be an Australian Citizen or Permanent Resident.
We offer a supportive work environment, opportunities for professional growth and development, and a chance to make a meaningful impact on patients' lives.
\We are committed to diversity, equity, and inclusion in the workplace. We encourage applications from diverse candidates who share our passion for making a difference in healthcare.
\