The Pharmaceutical Chemistry Sections (PCS) within the Scientific Evaluation Branch are looking for exceptional and motivated candidates to fill a number of vacant Principal Evaluator roles. PCS are responsible for the evaluation of chemistry, manufacturing, quality control (CMC) and biopharmaceutic data submitted by pharmaceutical companies in support of applications for new and variations to existing prescription medicines. Principal Evaluators lead teams of scientific evaluators and possess a high-level understanding of the CMC and regulatory aspects of prescription medicines. Successful candidates will be able to efficiently manage workload, apply a risk-branch approach to decision making, function effectively under pressure and be strong communicators. The key duties of the position include Leading a team responsible for the evaluation of chemistry, manufacturing, quality control and biopharmaceutic data supplied by pharmaceutical companies in support of new prescription medicines and variations to existing prescription medicines. Anticipating and establishing priorities and the delivery of high quality and timely evaluations and robust, risk-based regulatory decisions. Overseeing technical work with a high level of risk-based regulatory decisions and providing expert scientific and regulatory advice to a wide range of stakeholders. Ensuring evaluators maintain a high level of specialist, professional and/or technical expertise are supported in their role and that resources are utilised to optimum capacity. Developing and managing key strategic relationships and collaborations with a broad range of internal and external stakeholders. Identifying and leading business improvements and providing leadership in supporting change. Providing advice that influences the strategic direction of the Branch and, where appropriate, the Division. Working collaboratively with colleagues to help build organisational capability and a positive and motivated work environment. Representing the TGA and providing expert advice in national and international working groups where required.
