Regulatory Affairs Specialist

16 hours ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000
Job Opportunity

We are seeking a talented professional to fill the role of Regulatory Affairs Associate. In this position, you will play a crucial part in enabling the ongoing registration of life-changing healthcare solutions for patients in Australia and New Zealand.

  • 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.
  • Gain 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

Key Requirements:

  • Tertiary qualification in a life sciences field
  • At least 2 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

About Us:

We value innovation, collaboration, and teamwork. We are committed to making a positive impact on people's lives through our work in the pharmaceutical industry. If you are passionate about regulatory affairs and want to make a difference, we would love to hear from you

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