Regulatory Affairs Associate – Commercial Focus

Regulatory Affairs Associate – Commercial Focus (The position has been filled)

BENEFITS

• Excellent opportunity to join Pharmaceutical giant based in more than 150 Countries
• Permanent Role with Friendly, Professional Team
• Melbourne CBD location
• Be the Local Member of a Large, Global Regulatory Affairs Team

 

CLIENT

Our Client is one of the worlds largest manufacturers of generic therapeutic products, including OTC’s and prescription medicines. Their Australian Head Office is based near Melbourne’s CBD and is in need of an experienced Regulatory Affairs Associate to ensure the Company’s products meet Australian regulatory requirements. You will be supported by a global group of Regulatory Specialists that prepare dossiers and look after the overall needs of the business.

 

THE ROLE

To be successful in this role you will be commercially aware, target focussed and able to keep to deadlines! We are looking for someone that will make this role their own!

Your main responsibilities will be to prepare clones of OTC and prescription applications and perform gap analysis on dossiers prepared by experienced staff based in Head Office overseas. There will be a number of other tasks including:

• Co-ordination of regulatory and PV tasks
• Maintenance of registrations and listings with TGA
• Pharmacovigilance and ADR reporting
• The review and approval of advertising and promotional material prior to submission

 

SELECTION CRITERIA

To be considered for this role you must meet the following criteria:

• Science degree or higher in Pharmacology, Chemistry or relevant discipline
• Have a strong commercial awareness
• Working knowledge of clone applications for OTC’s & prescription medicines in Australia
• Working knowledge of TGA requirements and legislation.
• Excellent time management skills with the ability to work on multiple projects
• Excellent communication skills, written and verbal to allow you to communicate clearly with both internal and external stakeholders
• Ability to review and summarise regulatory requirements for therapeutic and non-therapeutic in international markets
• Good team player with a good work ethic and a friendly disposition
• Good computer skills with Microsoft Office and TGA databases

 

APPLICATIONS

To apply for this wonderful opportunity please submit your covering letter and updated resume by clicking the APPLY NOW button below. To discuss your suitability please call Helen, Natalie or Emily on 03 9516 0100 or after hours on 0438 620 434.

All applications will be treated in the strictest confidence.

Please Note: Unfortunately only short-listed candidates can be contacted due to high volume of applications.