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Regulatory Scientist

Overview

Our client is responsible for post-market monitoring of medicines and vaccines to ensure they continue to maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace along with the evaluation and monitoring of Risk Management Plans for high risk medicines. They also oversee access to products not on the Australian Register of Therapeutic Goods, but for which there is a clinical need, through the various special access programmes and clinical trial schemes.
  
They are also responsible for implementing a number of reforms to communication and education strategies, regulations and legislation relevant to medicine shortages, business processes and data analytics.
  
Start date
ASAP
  
End date   
Two roles available, 6 to 12 months contract    

Possibility of extension    
To be determined
  
Hours        
Full-time 
  
Location   
Canberra
  
Security Clearance Level
A Baseline security Clearance is desirable 
  
Specific duties include
  
The Regulatory Scientist will assist with the management of shortage notifications submitted by industry, with responsibilities for market assessments and evaluation of applications for supply of overseas-registered medicines to mitigate shortages of Australian medicines. They will also be responsible for handling phone and email enquiries.
  
The role requires extensive liaison with patients and consumers, the pharmaceutical industry, healthcare practitioners and other areas within the department. 
  
Key Responsibilities  

  • Evaluate documents, applications and submissions relevant to the approval process for supply of overseas-registered medicines in Australia.
  • Prepare a range of written communication materials, including correspondence with stakeholders, briefs, reports, scientific and/or technical documentation and policy papers.
  • Assist with the provision of expert advice to internal and external stakeholders.
  • Liaise, engage and collaborate with internal and external stakeholders to resolve complex and/or sensitive issues.
  • Assist with implementation of reform work and business improvements.
  • Contribute to team goals and broader organisational objectives by undertaking other tasks as required.

Key Capabilities  

  • The ability to work collaboratively and contribute as an effective team member
  • A sound understanding of the regulatory framework for therapeutic goods in Australia, including applicable standards and guidelines, or demonstrated ability to rapidly learn and apply this knowledge
  • Strong scientific analytical ability
  • Demonstrated ability to manage projects, work to tight deadlines and respond quickly to changing priorities
  • The ability to work flexibly in a high-pressure environment
  • High-level written and verbal communication skills
  • High-level interpersonal, negotiation and stakeholder management skills, including the ability to develop productive working relationships with external stakeholders to identify opportunities, facilitate cooperation and achieve outcomes

Selection Criteria
  
Mandatory requirements       

  • Candidates must be able to demonstrate:

A degree in pharmacy, pharmacology, chemistry/biochemistry, biology, or in another relevant science from an Australian tertiary institution, or comparable overseas qualifications.
  
Desirable     

  • Regulatory affairs, supply chain or quality assurance experience in the pharmaceutical industry; project or program management experience. 

If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
  
Kalpana Palaniyappa
0403 200 666  
kalpana.palaniyappa@calleo.com.au 

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