Regulatory and Quality Manager

Posted 4 May 2023

The Client

An ASX-listed biotechnology company seeking to improve the lives of patients suffering from neurological diseases such as Alzheimer’s Disease and Major Depressive Disease. They are currently transitioning from an early-stage drug discovery company to a global leader in drug development, having grown the size of their team by 40% over the previous two years. Their goal is to ultimately improve the lives of patients by developing novel and effective treatments for these and other related neurological diseases.

The Opportunity

You will be responsible for the organisation and management of all regulatory and quality affairs activities for our client. Working in this role, you will manage the development and implementation of strategies that ensure the fulfilment of their regulatory obligations and compliance with Quality Systems, cGMP, cGCP, and cGTP models. You will also liaise with key regulatory partners manage submissions to global regulatory authorities, including the TGA and FDA. Key responsibilities will include:

  • Monitoring compliance with all applicable regulations though internal audits, managing deviations, reviewing and approval of standard operational procedures and other Quality Systems reports.
  • Implementing processes and workflows to maintain QMS to ISO 13485 and 21 CFR (Part II).
  • Supporting regulatory inspections and Supplier Qualification Audits, coordinating responses, and maintaining all applicable documentation and records.
  • Developing, maintaining, and training on QA, Quality Systems, and Regulatory policies and procedures.
  • Interfacing with regulatory agencies, accreditation bodies, and customers on issues related to Quality and Regulatory systems and/or HREC/IRB issues.
  • Ensuring all activities related to human subject research are conducted in accordance with HREC/IRB determinations and approvals.

The Requirements

  • Tertiary qualifications in biological/life sciences or bachelor’s degree in science or pharmacy.
  • 5+ years’ experience working in regulatory affairs for the pharmaceutical industry or a regulatory agency.
  • Experience working with and implementing Quality Management Systems.
  • Demonstrated ability to collaborate with internal stakeholders and external consultants to drive and manage compliance with international regulatory agencies including the TGA. Experience with the FDA an advantage.

The Offer

Our client is offering a fantastic opportunity to be part of a growing team of professionals dedicated to delivering change to the lives of those touched by neurological diseases. Total remuneration includes an attractive base salary, access to both short-term and long-term incentives through ESOP, and bonuses paid annually. This role can be based anywhere in Australia. You will be expected to visit on-site in Sydney every 6 weeks for up to a week at a time.

For more information, you can email or contact Mark Thomas or Marilyn Jones at 1300 0 MEXEC for a confidential discussion about the role.

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