Senior Regulatory Affairs Professional

2 days ago

Melbourne, Victoria, Australia Axia HR Full time $80,000 - $120,000 per year
Your new company 
 
A global pharmaceutical leader that is paving the way in commercialization and development of quality medicinal products. They were the first to be granted a permit in their arena and are truly specialist in their area of expertise. With revenues reaching $6 million, they have two established R&D sites and a brand new state-of-the-art high volume manufacturing site in Victoria. Their headcount and product pipeline are expanding rapidly. Therefore, they're seeking a highly experienced Regulatory Affairs professional to join their growing team. This is a very exciting time to join an organisation that will be paramount to the future of healthcare.
 
Your new role
 
Reporting directly into the Regulatory Affairs manager, you will play a pivotal role in the organisation. As Senior RA Specialist, you must have the capacity to work well under pressure in a fast paced dynamic environment. You will be responsible for, but not limited to:
  • Management and leadership of various products ensuring compliance with all internal and external regulatory requirements for Australia
  • Managing on-going compliance requirements and develop regulatory strategies to support the business
  • Preparing documentation for regulatory dossiers, drug master files, licence renewals and responses to questions from regulatory bodies
  • Diligent and organised in your approach to workflow for legal and regulatory functions, including tracking progress and due dates of open matters, licensing and data entry
About You
 
You must be able to work independently to be considered for this opportunity and show resilience to changes. 
  • Degree qualified (Bachelors or higher)
  • At least 5+ years pharmaceutical industry experience (in Regulatory Affairs) 
  • Well versed in regulatory planning, submission preparations and discussions with regulatory bodies
  • Proficient with project planning and skilled in eCTD (advantageous)
  • Stellar attention to detail, strong organizational skills and manage multiple tasks professionally 
If interested please apply below or contact Sorcha Hayward @ for a confidential discussion  

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