A results-driven pharmaceutical professional with over 25 years of experience in quality and regulatory affairs across human and animal therapeutics. Regulated environments include a strong track record in TGA, FDA, EU, ISO and APVMA compliance.Industry sectors include manufacturing of sterile and non-sterile dosage forms, aseptic compounding, vaccines and medical devices, research and clinical stages, and through the supply chain from vendor to commercial supply.Excels in leading quality and regulatory functions, executing strategic initiatives, and guiding teams with a focus on risk and commercial outcomes. I champion quality as a strategic business imperative, driving operational efficiency and aligning stakeholders with corporate goals. Regulatory and quality background spans product life cycle activities, such as - Pre- and post-market regulatory processes for medicines and devices, listings, registrations and changes,- Advertising material and labelling review, - Permits, - Pharmacovigilance,- Quality management systems, including for example recalls, supplier management, investigations, change control, product complaints, technical writing, audit and gap analysis, compliance and risk management,- Laboratory operations, - Validation,- Transforming technical requirements into fit for purpose frameworks that meet business and customer needs.Additionally, I hold a doctorate in environmental life cycle assessment, applying knowledge to address emerging ESG challenges.As a member of executive teams, I share valuable insights as a compliance subject matter expert, contributing to operational management, budgeting, planning, and fostering a positive organisational culture rooted in values. My strategic mindset and dedication to continuous improvement drive me to address challenges methodically, blending structured planning with adaptive and innovative thinking.Embracing a democratic leadership style, I foster a supportive and inclusive environment, creating safe and trusting spaces that empower teams to achieve remarkable results. I firmly believe in the power of people and strive to cultivate competence and confidence among team members, enabling them to work collaboratively towards a common vision. Known for my sense of humour and commitment to personal growth, I embrace each day with a determination to excel and make a positive impact.