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Regulatory Affairs Associate – Complementary Medicines (The position has been filled)
Multinational Complementary Medicine Manufacturer
One Year Fixed Term Tenure With Possibility to Extend or go Permanent
Excellent Facilities, Friendly & Supportive Work Culture
Our client is a multinational company specialising in the manufacture of complementary medicines including solid and liquid dose. With facilities in the USA, Asia and Australia, the company prides itself in their ability to develop, deliver and manufacture various consumer health care products of the highest quality for their clients; from conception right through to commercialisation.
To employees, our client offers excellent facilities and a supportive, friendly and professional work environment.
This position is ideal for an individual experienced in legal compliance of pharmaceutical products with a focus on Complementary Medicines looking for the next step in their career. Our client is currently offering a one year fixed term tenure with a possibility to extend or go permanent.
The successful candidate will have few years’ experience working as a Regulatory Affairs Associate in Pharmaceutical Industry coupled with great listening skills, analytical skills and proficient time management skills to be able to complete tasks and projects on time.
You will be required to perform the following tasks:
Prepare proposals for products (Complementary Medicines) to be listed with TGA
Collect and prepare all relevant product data/information necessary to achieve product TGA listings
Review evidence and claims for all products undergoing TGA listing applications
Complete product submissions
Manage all product listings
Ensure label accuracy and compliance with relevant regulations
Provide regulatory advice to R & D, Sales, and Marketing Departments
Address rejections or suggestions for improvement from relevant regulatory bodies
Closely monitor and educate yourself on all relevant regulatory updates and their effect on business
Provide regulatory guidance in risk assessments and provide regulatory recommendations to busniess
To be successful in your application you must meet the following criteria:
A Bachelor’s Degree or higher in Medical, Health or Life Sciences
3+ years’ experience in a similar role as a Regulatory Affairs Associate
Experience in Pharmaceutical Industry with emphasis on Complementary Medicines
Broad knowledge and a proven track experience with the Australian laws and regulations in Pharmaceutical cGMP
Previous experience in submitting and managing TGA product listings will get you shortlisted
Additional regulatory experience within food is a bonus
You must be a positive person with a proactive and professional attitude
Ability to multitask and manage multiple important projects is a must
A good work ethic, excellent interpersonal skills and the ability to work as a team member or autonomously
You need to be able to lead and train and have excellent written and verbal communication skills with a proven ability to meet goals, targets and deadlines
Experience in MS Office Software is necessary
To apply for this role, please click the ‘Apply Now’ button below and send your updated resume with a covering letter to CS Executive Group. For a confidential discussion about this role, please call Jo or Helen on +61 3 9516 0100 during office hours and +61 3 411 197 171 after hours.
We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of candidates we receive on a daily basis, we can only contact those with suitable qualifications and experience. If on this occasion you are not successful, your resume will remain on our database and be considered for future suitable roles.