Regulatory Associate Consultant

23 July 2019

Healthcare · Pharmaceutical · Medical · Regulatory

The company
mexec careers are privileged to partner with Australia & New Zealand’s leading Pharmaceutical & Medical Device commercialisation company. With over 18 years of experience & a team of over 90 employees they provide local & international companies’ excellence in advice, strategy and support.

The role
Reporting to the Regulatory Services Manager, you will contribute to the Regulatory and Quality consulting practice. The Associate Consultant is responsible for the preparation and submission of a range of regulatory applications for Australia and New Zealand. The Associate Consultant supports the delivery of a variety of projects, including the registration and listing of pharmaceuticals, biologicals and medical devices, working closely with the Regulatory Consultants, Senior Consultants, Project Leaders and/or Regulatory Services Manager to deliver a superior client experience and optimise project outcomes.

• Provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices in Australia and New Zealand.
• Provide support to clients with the maintenance of current registrations and listings.
• Review, critically evaluate, prepare and submit regulatory dossiers to the TGA and Medsafe.
• Assist clients in responding to TGA and Medsafe questions.
• Assist senior members of the team in the preparation of complex regulatory applications for submission to the TGA and Medsafe agencies.
• Assist with development of proposals.
• Develop a subject matter expert area(s).
• Review and QC applications, regulatory documentation as required.

Expertise required
• Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline.
• A minimum of 3 years of experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
• Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.
• Reasonable computer literacy.
• Proven experience dealing with a high level of confidentiality.
• Good problem solving and project management skills.
• Ability to work to deadlines.
• Attention to detail.
• Excellent written and spoken communication and interpersonal skills.
• Reliable.
• Interest in the practice of consulting.
• An appetite for learning and development.

The offer
Our client consistently offers excellence in their service delivery that makes a difference to people’s lives through improved health outcomes. A flexible workplace that is diverse and inclusive, you will be privileged to be part of their progressive team.

Your application
If you are interested in joining our client in this exciting new challenge, please call Marilyn Jones on 0437 332 272 for a confidential discussion and/or email your résumé with your cover letter: Australian Residents or Citizens will only be considered.


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