Manager, Regulatory, Quality & Compliance

Role Description

• The Manager is responsible for the day-to-day operational management of the assigned project portfolio and direct reports in the Regulatory, Quality & Compliance function. The Manager is also responsible for delivering the business unit’s objectives, as agreed with the Senior Manager. This includes project management and people management to ensure optimum project outcomes. In collaboration with the Senior Manager, the Manager is responsible for developing strategic plans to drive the development and growth of the business unit.
• The role is responsible for the implementation and maintenance of systems for operational efficiency of Regulatory, Quality & Compliance project teams, management of customer relationships and the support of new business initiatives and opportunities.
• The role is accountable for supporting the development and implementation of business development initiatives, for meeting agreed financial and productivity objectives, ensuring teamwork, cross-functionality, and efficiencies across the business, encouraging value based professional conduct, and delivering excellent client service.

Role Responsibilities

• Adherence to Commercial Eyes' values, policies and quality management systems.
• Support 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 business.
• Provide high quality work that contributes to client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the RQC service offering.
• Contribute to and actively participate in the business planning processes.
• Work closely with the Senior Manager on matters of strategic importance and provide relevant insights to the Consulting Leadership team.
• Performance manage and actively develop direct reports.
• Provide assistance and support to the Senior Manager in areas of the business unit management, including the development and implementation of strategic plans, as required.
• Provide specialist knowledge, advice and guidance on best practice and develop resources to enable the delivery of high-quality Regulatory, Quality & Compliance services.
• Review and QC applications, regulatory, quality and compliance documentation as required./

Project & Client Management

• Lead Regulatory, Quality & Compliance project teams, in accordance with the Strategic Priorities, Purpose and Values.
• Act as Project Team Leader, participate in assigned projects and support project teams as required.
• Act as a subject matter expert.
• Supervise, mentor and coach other members of the project team as required.
• Provide project leadership including client liaison, project scoping and proposal development, project team resourcing, project management and delivery and client follow up.
• Deliver strategically and technically sound project outcomes, reports, and presentations according to agreed deadlines, project budget and client requirements.
• Monitor project team achievement to targets and task completion. Adjust plans and provide mentoring as required.
• Manage day-to-day resources, with support from the Senior Manager.
• Assist in the design of project team structure and governance.
• Develop the skills and abilities of project team members so they can deliver the optimal performance required to meet changing business needs.
• Assist project team members with important client activities and act as direct client contact to address and resolve client concerns when escalated by the project team.

Business Growth

• Proactively develop business development initiatives and work 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.
• Lead contributor to client retention. 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 RQC service offering.
• In conjunction with the Head of RQC or Senior Manager translate these conceptual discussions into concrete project proposals which provide a realistic description of the scope of work to be undertaken and a competitive cost estimate.
• Contribute to the RQC 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 RQC 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 2 years’ consulting experience and 10 years’ experience in JAPAC and/or Australian and New Zealand regulatory affairs and/or quality, 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.
• Experience in the review, critical evaluation and presentation of clinical and quality data.
• Proven experience in people supervision.