positions available now

Commercial Eyes Recruiting: Consultant, Regulatory, Quality & Compliance

 

The Opportunity

The Consultant works within the Regulatory, Quality & Compliance team to deliver a range of regulatory applications for Australia and New Zealand.  The Consultant manages client projects, working closely with other members of the team, to deliver a superior client experience, optimise project outcomes, and contribute to the culture and capabilities of the team.

 

Duties

  • Manage the registration and listing of medicines or medical devices in Australia and New Zealand.
  • Provide support on regulatory activities requiring a sound knowledge of the type and quality of evidence necessary for new medicines registrations or medical device inclusions, as well as related life cycle management activities.
  • Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.
  • Review, critical evaluate, prepare and submit regulatory dossiers to the TGA and Medsafe.
  • Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.
  • Assist senior members of the team in the preparation of complex regulatory applications for submission to the TGA and other regulatory agencies.
  • Assist clients with the maintenance of current registrations and listings.
  • Assist clients in responding to regulatory agency questions.
  • Attend meetings/teleconferences with clients and/or TGA or Medsafe as required.
  • Undertake project and client management as required.
  • Mentor junior staff as required.
  • Build strong interpersonal networks across the life sciences sector and draw on these to identify potential short and long-term business opportunities for Commercial Eyes.
  • Assist with development of proposals.
  • Liaise with other groups within Commercial Eyes as required.

 

Position Requirements

  • Undergraduate qualifications in pharmaceutical sciences or other scientific discipline.
  • A minimum of 5 years’ experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
  • Experience in the review, critical evaluation and presentation of clinical data.
  • Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.
  • Reasonable computer literacy.
  • Proven experience dealing with a high level of confidentiality.
  • Proven problem solving and project management skills.
  • Attention to detail.
  • Interest in the practice of consulting.
  • High level written and oral communication skills.

 

Preferable requirements:

  • Post-graduate qualifications in a relevant discipline.
  • Previous consulting experience.
  • Willingness to travel as required.

 

The Rewards

  • Work for a company consistently delivering excellence.
  • Deliver work that makes a difference to people’s lives through health.
  • Be a member of a team who supports and cares for each other.
  • Be part of an inclusive and diverse working environment.

 

Please note:

  • Commercial Eyes does not accept applications from recruitment agencies.
  • To apply for this role you must be a permanent resident or citizen of Australia. 

 

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

If you would like more information, email our People, Learning & Performance department at [email protected]

This entry was posted in Commercial Eyes, Recruiting, Regulatory Services and tagged , , , , .
Copyright © 2020 Commercial Eyes