Senior Regulatory Affairs Associate

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.