Job: Senior Regulatory Consultant

  • New growth opportunity
  • Market leading company
  • Diversity of projects

The company

Our client is integral to all stages of the product development cycle and subsequent success for international & Australasian companies across the healthcare landscape. Their clients include leading local & international pharmaceutical, biotechnology & medical device organisations. Definitely no ‘siloing’ in this opportunity, your exposure to projects across multiple companies and markets will ensure you become an expert in your field & be integral in ensuring our client maintains their position as the preferred provider of choice.

The role

Due to continued growth, our client is seeking a new employee to join their Regulatory Services business unit as a Senior Regulatory Consultant. You will be joining a highly experienced team of over 70 employees of whom their customers comment; ‘are professional, responsive, always deliver on time (or before), highly connected & with their finger on the pulse of the industry.’

You will work with our client’s regulatory team in assisting companies at all stages of the product development cycle from review of potential products, submission of regulatory applications & preparation of quality documentation.

  • Support to clients on the registration and listing of pharmaceuticals, biologicals & medical devices.
  • Critical evaluation, preparation and submission of regulatory dossiers to the TGA & Medsafe.
  • Preparation of literature-based submissions, including the preparation of associated overviews and summaries.
  • Maintain knowledge and oversight of the relevant national and international regulatory standards: including FDA, TGA, Medsafe, EMA, to allow commercialisation of their customers’ products.
  • Prepare and/or assist in the preparation of technically complex regulatory dossiers to meet compliance and commercialisation requirements.
  • Negotiate with regulators to obtain desired outcomes.
  • External stakeholder relationship management.

Your expertise

  • Minimum five years’ experience in a regulatory affairs role
  • Experience in literature-based submissions and the review of the bibliographic data to support claims of efficacy, safety & relevant issues
  • Experience in the review, critical evaluation and presentation of clinical data
  • Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.
  • High level written and oral communication skills
  • Highly organised with the ability to multi-task and work independently and collaboratively
  • Tertiary qualification in an appropriate field – Pharmaceuticals, Biotechnology, Science, Chemistry, Pharmacy

The offer

This role will be based in Melbourne or potentially Sydney, and some planned travel will be required. You will enjoy a very flexible, supportive & progressive environment. As a valued member of this team, you will have the opportunity to demonstrate your talent and shape this growing business.

 

If you are interested in joining our client in this exciting new challenge, please call Marilyn from Marilyn Careers on 043 7332 272 for a confidential discussion and email your resume & cover letter to Marilyn at careers@marilyncareers.com.

 

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