Our client manufactures a variety of therapeutic goods and devices. Based in Melbourne, they are in need of an experienced Regulatory Affairs Associate to ensure that the Company’s products meet local regulatory requirements.
Working three days per week and reporting to the Quality Manager, you will be responsible for the following:
Maintaining the registrations and/or listings of existing products with regulatory bodies in Australia and internationally
Preparation, review, submission and follow-up of regulatory affairs submissions to relevant regulatory authorities for new products and line extensions in accordance with agreed time frames
Liaison with external consultants in the preparation of regulatory submissions as required
Continue to build on established relationships with the TGA, NICNAS, Medsafe and other regulatory bodies
Review and propose strategies for the use of new and innovative ingredients
Assist in the response to medical and technical enquiries from health professionals, stakeholders and consumers
Carry out review and approval of advertising and promotional material prior to submission where required to regulatory authorities
Science degree or higher in Pharmacology, Chemistry or similar
A strong working knowledge of the regulatory and legislative requirements for therapeutic and non-therapeutic products in Australia
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
Well organized with strong attention to detail for maintaining accurate submission reports and regulatory related records
Good team player with a good work ethic and a friendly disposition
Good computer skills with Microsoft Office and TGA databases
To apply for this wonderful opportunity please forward your covering letter and updated resume by using the APPLY NOW button below. All applications will be treated in the strictest confidence.
To discuss the role please call the team at ChemSkill on 03 9516 0100.
The CVs of unsuccessful candidates will remain on our database and will be considered for future positions.
Please Note: Unfortunately only short-listed candidates can be contacted due to high volume of applications.