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Job details

Location
Surrey Hills
Salary
$90000 - $100000 per annum
Job Type
Full Time
Ref
BH-39973
Contact
Jo Turner
Contact email
Email Jo
Contact phone
+61 3 9938 7120
Posted
11 days ago

Job details

Location
Surrey Hills
Salary
$90000 - $100000 per annum
Job Type
Full Time
Ref
BH-39973
Contact
Jo Turner
Contact email
Email Jo
Contact phone
+61 3 9938 7120
Posted
11 days ago
About the company 
Our client is a leading pharmaceutical provider of high-quality generic prescription, injectable and over-the-counter medicines.
 
About the opportunity 
The role is to complete regulatory activities to support business growth and the continued supply of products in the Australian and New Zealand markets.
 
Duties  
  • Complete due diligence and remediate in-licensed dossiers against the TGA mandatory requirements
  • Compile and submit dossiers, post-approval variations, and GMP clearances
  • Maintain the company’s labels, Product Information, and Consumer Medicine Information in accordance with TGA standards and conditions of registration
  • Support or lead pre-submission meetings with the regulatory agencies to seek clarity on data requirements for the registration or maintenance of products
  • Review change controls from manufacturers and provide regulatory assessment according to the current TGA and Medsafe guidelines and the company’s internal processes
  • Assist with the reporting of medicine shortages to the TGA in accordance with Australian legal requirements
  • Stay up to date with all applicable legislation, regulations, and guidelines relevant to prescription and OTC medicines supplied by the company
  • Provide regulatory guidance and advice to commercial, quality, supply chain, sales, and marketing, business partners, or third-party manufacturers
  • Develop and maintain effective relationships with the regulatory bodies, internal and external key stakeholders including internal teams
  • Liaise with external regulatory consultants for any outsourced activities
  • Preparation and implementation of internal procedures/SOPs to streamline regulatory processes
  • Respond to the TGA requests on GMP non-compliance signals to justify the continued supply of products
  • Assist with the training of other regulatory team members in his/her area of expertise by imparting/sharing of regulatory knowledge
 
Skills and Experience 
  • Bachelor’s degree in either Medical, Health, or Life sciences
  • Have extensive years of regulatory experience within pharmaceutical companies
  • Strong analytical and writing skills
  • Have strong problem-solving skills
  • Outstanding communication and interpersonal
  • Excellent organisational and project management skills
 
Why this opportunity is right for you 
This is a Full-time 2-year contract opportunity based in Melbourne’s South Eastern suburbs.  
 
How to Apply 
Click apply or contact Jo Turner, Senior Specialist Manager on 03 9938 7120 for a confidential discussion. 
 
 
 

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