Role Description:The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality, and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of GMP Clearance applications as well as a range of compliance documents or related quality activities. The Associate Consultant also supports the delivery of a variety of projects, working closely with the Regulatory, Quality & Compliance Administrators, Associates, Associate Consultants, Consultants, Senior Consultants, Manager, Senior Manager, and/or Head of Business Unit to deliver a superior client experience and optimize project outcomes.Role Responsibilities:General:Adherence to ProductLife Group's values, policies, and quality management systems.Perform compliance activities to meet ProductLife Group and client Quality objectives.Support audit requests as required.Manage and prepare GMP clearance applications for submission to the TGA and/or other regulatory agencies, as required.Provide regulatory, quality, and compliance support to clients relating to the registration/listing of pharmaceuticals, biologicals, and medical devices and the ongoing maintenance of these.Assist clients in responding to agency questions.Provide support to clients by assisting more senior members of the team with regulatory, quality, and compliance activities.Prepare, review, and update quality documentation.Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering.Qualifications / Experience / Skills:Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline.A minimum of 3 years of experience in Australian and New Zealand Quality or Regulatory Affairs, preferably in a commercial environment.Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures is preferable.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.Interest in the practice of consulting.An appetite for learning and development.
Job Title
GMP Clearance Associate