Regulatory Affairs Specialist – Complementary Medicines

Regulatory Affairs Specialist – Complementary Medicines (The position has been filled)

• Excellent Opportunity to Join Market Leader in the Complementary Medicines Space
• Excellent Career Progression Opportunity
• Growing Company, Excellent Facilities and Culture

 

CLIENT

Our client is a well known and fast growing manufacturer and supplier of complementary medicines and wellness products for the Australian and global marketplace. Committed to improving the health and wellbeing of people, our client is dedicated to providing the highest quality, specialist formulas based on the most recent clinical research.

 

ROLE

Due to growth, the regulatory team based at the Head Office near the CBD, requires one more Regulatory Affairs Specialist to assist with the listing and/or registration and compliance of their many complementary products.

Some of the duties associated with this role include:

• Regulatory compliance of therapeutic and non-therapeutic products
• Product & label accuracy and compliance with relevant regulations and codes of practice
• Product listings and/or registrations as required
• Development and maintenance of product dossiers (i.e. Evidence tables, Specifications, Listings, etc.)
• Act as an interface between the NPD / innovation and marketing processes, providing technical and regulatory input for local and export products when needed
• Provide input into government consultations affecting the business, where required
• Contribute to the development, implementation and maintenance of regulatory SOPs, procedures and data management to ensure due diligence and sponsor obligations are maintained in the domestic market
• Contribute to advertising complaint responses
• Provide regulatory advice to NPD, sales & marketing teams

 

REQUIREMENTS

This busy role requires someone with a ‘can do’ attitude, proven track record and ability to be part of a champion team.

A summary of required criteria include:

• Bachelor degree or higher qualifications in Science, pharmacology, pharmacy or related area
• Working knowledge of ARGCM, TGAC, TGO 92 and Evidence Guidelines
• One to two years’ of regulatory affairs experience, especially the preparation and lodging of listings and/or registrations of Complementary Medicines with TGA
• Excellent communication skills
• Understanding of regulatory requirements for therapeutic and non-therapeutic products
• Experience in implementing regulatory compliance across various international markets will be well regarded
• Understanding of legal issues relating to product registration and marketing
• MUST have a good eye for detail, superior written communication skills, be a good team player and a problem solver

 

APPLICATIONS

To discuss this excellent opportunity please call Helen on 03 9516 0100 or after hours on 0438 620 434 for a confidential discussion. To apply, please click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.

 

THANK YOU

Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.