Regulatory Consultant – via mexec careers

29 August 2019

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

The Consultant/Senior Consultant works within the Regulatory Services 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.

♦ To primarily support regulatory activities requiring a sound knowledge of the type and quality of clinical and non-clinical evidence necessary to support new medicines registration, related life cycle management and maintenance activities.
♦ To provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices in Australia.
♦ Review, critical evaluation, preparation and submission of regulatory dossiers to the TGA and Medsafe.
♦ Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.
♦ Assist clients in responding to regulatory agency questions.
♦ Assist clients with the maintenance of current registrations and listings.
♦ Prepare and submit safety related updates to Product Information documents at varying levels of complexity.
♦ Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.
♦ Attend meetings/teleconferences with clients and/or TGA or Medsafe as required.
♦ Build strong interpersonal networks across the life sciences sector and draw on these to identify potential short and long-term business opportunities.
♦ Liaise with other groups within the company as required.
♦ Mentor junior staff as required.
Expertise required
♦ 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.
♦ A degree in science, pharmacy or a related discipline.
♦ High level written and oral communication skills.
♦ Proven problem solving and project management skills.
♦ Reasonable computer literacy.
♦ Ability to deal with high level of confidentiality.
♦ Post-graduate qualifications in a relevant discipline.
♦ Previous consulting experience.
♦ Willingness to travel as required.

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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