positions available now

Tag Archives: Regulatory Services

Commercial Eyes Recruiting: Regulatory Services Associate

Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas…   The role… Operating within the Regulatory Services Business Unit at Commercial Eyes, and reporting to the Regulatory Services Manager, this role will prepare routine regulatory … Continue reading

Posted in Commercial Eyes, Recruiting, Regulatory Services | Tagged , , | Comments Off on Commercial Eyes Recruiting: Regulatory Services Associate

Making the most of complementary medicines reforms

In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms.    One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications.  All … Continue reading

Posted in Regulatory Services, TGA | Tagged , , , | Comments Off on Making the most of complementary medicines reforms

New ‘SmPC’ Format for the Australian Product Information

The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients.  The new form will be implemented over a … Continue reading

Posted in Regulatory Services, TGA | Tagged , , , | Comments Off on New ‘SmPC’ Format for the Australian Product Information

Transition to eCTD is gaining momentum in Australia

At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for … Continue reading

Posted in Commercial Eyes, E-Health/Technology, Regulatory Services, TGA | Tagged , , | Comments Off on Transition to eCTD is gaining momentum in Australia

Stressed? Well your products should be!

Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier. Assay … Continue reading

Posted in Life Sciences Industry, Regulatory Services, TGA | Tagged , , | Comments Off on Stressed? Well your products should be!

Medicine labels: TGO 91 and TGO 92. What’s the impact?

Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements: Therapeutic Goods Order No. 91 – Standard for labels of prescription and … Continue reading

Posted in Life Sciences Industry, Regulatory Services, TGA | Tagged , , | Comments Off on Medicine labels: TGO 91 and TGO 92. What’s the impact?

Commercial Eyes Recruiting: Regulatory Services Manager

Commercial Eyes has a great opportunity for a Regulatory Services ManagerReporting to the Director, Regulatory Services, the Manager is responsible for the day to day operational management of the regulatory team and the assigned project portfolio within the Regulatory Services … Continue reading

Posted in Commercial Eyes, Regulatory Services | Tagged , , | Comments Off on Commercial Eyes Recruiting: Regulatory Services Manager

Commercial Eyes recruiting: Regulatory Consultant

Commercial Eyes has a unique opportunity for an experienced professional to join our Regulatory Services team In this role, you will be providing Regulatory Affairs and Quality consulting services to the clients of Commercial Eyes. This position may be based … Continue reading

Posted in Commercial Eyes, Regulatory Services | Tagged , | Comments Off on Commercial Eyes recruiting: Regulatory Consultant
Copyright © 2014 Commercial Eyes