regulatory affairs associate in Eastern Suburbs Melbourne

posted
contact
samantha lin, randstad
job type
permanent
apply now

job details

posted
location
eastern suburbs melbourne, victoria
specialism
science & technology
job type
permanent
working hours
Part-Time
experience
5 years
reference number
90M0374152_1548743083
contact
samantha lin, randstad
apply now
Apply with

job description

Role responsibilities:

  • Maintain the registrations and/or listings of existing products with regulatory bodies in Australia and internationally
  • Prepare, review, submit and follow-up of regulatory affairs submissions to relevant regulatory authorities for new products and line extensions in accordance with agreed time frames
  • Preparation and review of Material Safety Data Sheets (MSDS) for the company’s finished products
  • Administer the company’s database of MSDS documentation for raw materials
  • Actively participate and contribute to the New Product Development (NPD) Meetings
  • Liaise with external consultants in the preparation of regulatory submissions where required
  • Monitor the regulatory environment to ensure that the company’s products meet legislative requirements
  • 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
  • Review and approve material on company websites to ensure compliance with applicable regulations
  • Assist in providing regulatory, training and guidance to other departments
  • Preparation of regulatory documentation of exporting of products from Australia

Essential criteria:

  • Science degree or equivalent qualification
  • 5 years relevant experience in regulatory affairs
  • Excellent communication skills, written and verbal with the ability to communicate clearly with both internal and external stakeholders
  • A strong knowledge of the regulatory and legislative requirements for therapeutic and non-therapeutic products in Australia
  • Ability to review and summarise the regulatory requirements for therapeutic and non-therapeutic products in international markets
  • Strong attention to detail for maintaining submission reports and regulatory related records
  • Computer skills in spreadsheet, word processing and Australian TGA databases
  • Signatory on submissions to Australian regulatory authorities
  • Authorise release of Material Safety Data Sheets for finished products
  • Prepare regulatory submissions for local and international markets

If you are interested in this part time Regulatory Affairs role and believe you meet all the essential criteria noted above, please call Samantha Lin on (03) 9590 2224 for a confidential discussion.

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

skills

Exciting Regulatory Affairs Associate Role

qualification

Science degree
Relevant experience in regulatory affairs

educational requirements

Bachelor Degree