Senior Consultant, Regulatory, Quality & Compliance

Role Description The Senior Consultant works within the Regulatory, Quality & Compliance team to deliver a range of product development projects and regulatory applications in Australia, New Zealand and in Japan and Asia Pacific (JAPAC) region. The Senior 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. Role Responsibilities Adherence to Commercial Eyes' values, policies and quality management systemsSupport cross-collaboration within the business by fostering relationships and collaborating with other business units to drive innovation, create efficiencies and expand service offering across the businessProvide high quality work that ensures client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the RQC service offeringsWillingness to travel as required. Project & Client Management Act as Project Manager, provide project leadership including client liaison, project scoping and proposal development, project team resourcing, project management and delivery and client follow up.Act as a subject matter expert.Support product development and regulatory activities requiring a sound knowledge of the type and quality of chemistry, manufacturing and controls (CMC) and clinical and non-clinical evidence necessary to support new medicines registrations and medical device inclusions, related life cycle management and maintenance activities.To provide support to clients on the product development, registration and listing of pharmaceuticals, biologicals and inclusion of medical devices.Review, critical evaluation, preparation and submission of regulatory documentation.Review and QC applications, regulatory, quality and compliance documentation as required.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, listings, and inclusions.Prepare and submit safety related updates to Product Information documents at varying levels of complexity.Supervise and mentor other members of the project team as required.Develop the skills and abilities of project team members so they can deliver the optimal performance required to deliver the project.Deliver strategically and technically sound project outcomes, regulatory submissions, reports, and presentations according to agreed deadlines and client requirements.Attend meetings/teleconferences with clients and/or regulatory authorities as requiredBuild strong interpersonal networks across the life sciences sector and draw on these to identify potential short and long-term business opportunities for Commercial Eyes. Business Growth Contribute to the BUs business growth efforts by proactively identifying business development opportunities and working with existing and potential clients in the healthcare sector to anticipate and understand their business needs and identify areas or activities with which CEPL can assist.Contribute to client retention by developing strong relationships with existing clients and providing high quality consulting services to build client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the Business Unit’s service offering.Represent company externally, as a brand ambassador, with a goal of networking and relationship building with existing and potential clients.Achievement of KPI's as per business plan growth objectives. Qualifications / Experience / Skills A degree in science, pharmacy, or a related discipline.Post-graduate qualifications in a relevant discipline preferable.A minimum of 8 years’ experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.Comprehensive knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.Experience in technical/medical writing, particularly associated with therapeutic product requirements.Regulatory experience in jurisdictions outside of Australia and New Zealand, desirable.High level written and oral communication skills.