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Regulatory Affairs Associate

Kelly Scientific Resources works in partnership with many leading organisations across a variety of industry sectors and we are always looking for high calibre Regulatory Affairs Associates.

The Regulatory Affairs Department is the interface between a company and regulatory bodies (TGA/FDA/APVMA/NICNAS). The department ensures the maintenance of a company’s existing product licenses and liaises with authorities regarding any changes to labeling and packaging. Some departments will have major strategic input into the development process and will vet clinical development plans prior to implementation to ensure that adequate data is collected to satisfy the regulatory authorities.

Typical Responsibilities of Regulatory Affairs Associates:

  • Evaluate, prepare and submit drug registration applications.
  • Assist with responses to deficiency letters and other requests for data from regulatory agencies
  • Maintain registration of currently approved products.
  • Maintain and implement relevant importation/exportation licenses and the co-ordination of pure substance requests.
  • Develop and maintain good working relationships with internal departments, health authorities and industry bodies.
  • Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products.
  • Provide brand/Marketing support for products marketed locally
  • Provide regulatory documentation required by other company functions or businesses.
  • Ensure all business activities comply with relevant Acts, legal demands and ethical standards.
  • Develop packaging for new & existing products and comply with government regulations.
  • Review labelling, product information, consumer medicine information for compliance with relevant regulations and codes
  • Maintain contact with officials of the Australian TGA (and other regulatory bodies MOHNZ, FDA-USA, and industry associations through attendance at meetings, conferences and seminars as appropriate
  • To provide regulatory input to new product development and current product implementation for designated therapeutic areas.

Requirements:

  • Undergraduate qualifications in Health science or a related discipline.
  • Broad based regulatory experience within the pharmaceutical or device/diagnostic industry.
  • Highly developed analytical skills and the ability to communicate effectively with government agencies and internal/external customers

If you are seeking temporary or permanent opportunities as a Regulatory Affairs Associate, then we would like to hear from you. For further enquiries contact your nearest Kelly Scientific Resources branch:

Adelaide: 08 8409 8821 or email ksrsa@kellyservices.com 
Brisbane: 07 3405 3326 or email ksrqld@kellyservices.com 
Melbourne: 03 9204 4204 or email ksrvic@kellyservices.com 
Perth: 08 9229 1888 or email ksrwa@kellyservices.com 
Sydney: 02 9246 6030 or email ksrsyd@kellyservices.com 

 

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