Regulatory Affairs Associate – Complementary Medicines

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

 

COMPANY

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.

 

ROLE

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

 

SELECTION CRITERIA

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

 

APPLICATIONS

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.

 

THANK YOU

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.