regulatory affairs associate in Australia

melissa tuli, randstad
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healthcare & medical
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melissa tuli, randstad
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job description

The Company:

My client is a global Pharmaceutical company based in Melbourne CBD. Due to recent growth, they are looking for an experienced Regulatory Affairs professional. Being a global organisation, they are looking for a candidate with experience in TGA and international standards as you will be working closely working with the teams in the UK and USA.

Key duties and responsibilities:

Your main duties within this role will include but not limited to the following;

  • Evaluate technical documentation and generate comparison reports to assist in decision making of raw material and supplier selection
  • Ensure all documents meet regulatory standards
  • Ensure regulatory activities are updated as per the changes in dossier
  • Be a part of New product development process from start to finish
  • Facilitate process development and validation activities
  • Ensure the specification of raw materials, intermediates and finished products are compliant as per the regulatory standards
  • Oversee the manufacturing of registration and commercial batches
  • Communicate effectively with internal and external stakeholders

Qualifications and experience:

  • Bachelors degree in Chemistry, Pharmaceutical Science/Engineering, or other related disciplines
  • Minimum 3 years of experience in a pharmaceutical manufacturing is desirable
  • Experience in product technology transfer and pharmaceutical quality systems is essential
  • Working knowledge of GMP is essential
  • Experience in manufacturing of injectable products is desirable

If you feel that you would be suitable for this role click "APPLY NOW" or alternatively email Melissa Tuli on to discuss the role further.

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.


("regulatory affairs" OR "reg affairs" OR "scientific affairs" OR "government affairs" OR "medical affairs" OR "regulatory professional" OR "regulatory professionals")


•Bachelors degree in Chemistry, Pharmaceutical Science/Engineering, or other related disciplines

educational requirements

Bachelor Degree