Executive level 1 - senior evaluator - pharmaceutical chemistry sections

Executive Level 1 - Senior Evaluator - Pharmaceutical Chemistry Sections

Do you have a desire to fully utilise your strong technical and analytical skills to play a crucial role in delivering better health and wellbeing outcomes for the Australian Public?

The Pharmaceutical Chemistry Sections at the Therapeutic Goods Administration (TGA) are seeking suitably qualified candidates for multiple Senior Evaluator positions. Successful applicants will be responsible for independently analysing and critically evaluating complex quality, manufacturing and bioequivalence data in support of prescription medicine submissions and preparing high quality scientific reports based upon regulatory and legal requirements. As a Senior Evaluator, you will have supervisory responsibilities including peer review, coaching, and professional support as well as involvement in and leading continuous improvement initiatives.

Key responsibilities include:

• Lead the evaluation of complex data relating to the safety, quality and efficacy of therapeutic goods, ensuring decisions are evidence-based and aligned with regulatory standards.
• Interpret and apply legislative frameworks, exercising sound judgement to ensure compliance and informing regulatory decision-making.
• Prepare and oversee the development of high-quality written materials, including complex scientific and technical reports, briefs, and correspondence for a range of stakeholders, including senior executives.
• Engage and collaborate with internal and external stakeholders to resolve complex, sensitive and high-risk compliance issues in accordance with TGA requirements.
• Contribute to the design and implementation of regulatory reform initiatives and continuous business process improvements to enhance organisational performance.
• Represent the Therapeutic Goods Administration (TGA) at cross-agency meetings, national and international forums, and stakeholder engagements, influencing outcomes and promoting best practice regulation.
• Provide leadership, supervision and mentorship to evaluators, including quality assurance and review of technical assessments and reports.
• Drive team performance and contribute to broader organisational priorities by fostering a collaborative, high-performing work environment.
• Undertake additional responsibilities as required to support strategic and operational objectives.
• Work within an internationally recognised regulatory authority, contributing to the protection and promotion of public health through ensuring timely access to safe and effective medicines for Australians.
• Develop and demonstrate advanced expertise in pharmaceutical regulation, aligning with contemporary national and international best practice.