Director of Regulatory and Medical Affairs

Job Description

Director of Regulatory and Medical Affairs Hemisphere HR Sydney, New South Wales, Australia 2 days ago Be among the first 25 applicants Our client is a well-established and highly reputable company operating across multiple markets. As a market leader, this organization has cultivated a culture that promotes diversity, inclusivity, and flexibility. They encourage creativity through supportive and empowering leadership, making it a truly fulfilling environment for professional growth. The country, region and organisation has continued successful growth over many years. With additional investment we are looking at accelerating that growth further to take advantage of opportunities we have identified. The Director of Regulatory and Medical Affairs is responsible for the Regulatory Affairs and Medical Commercial strategy and operations for the ANZ region. This role could be suitable for someone who is looking to step up from a Head of level and looking for the next step in their career. This role necessitates a robust commercial acumen and deep understanding of the Regulatory requirements for various Health Authority Organisations. This role is instrumental for regulatory compliance, navigating the complex regulatory landscapes of different regions to bring our innovative products to market faster, staying informed about regulatory trends and upcoming changes to anticipate and adapt to new requirements and collaborating internally and externally to ensure our innovation is aligned with regulatory expectations and market needs. In addition, this role will drive the development and execution of the Medical Commercial strategy and plan in line with commercial strategy throughout the product lifecycle; providing regional input to ensure high professional and ethical standards for Regulatory strategies and Medical Commercial strategies to support cross functional team’s education strategy, marketing support and customer engagement. Key Responsibilities: Leadership and Management: Provide visionary leadership, develop their team to become best-in-class professionals, building their commercial acumen and utilising their regulatory knowledge to deliver a competitive edge. Regulatory Advocacy: Hold strong relationships with Health Authority Organisations to influence decision-making where appropriate to secure best potential results. Medical Marketing: Utilising their understanding of the science behind complementary medicine to create strategies to influence prescribers of products. Strategy Support: Provide strategic support to the overall regional medical strategy and collaborate cohesively with key stakeholders, including Regulatory Affairs, Pharmacovigilance (PV), Quality Assurance, Marketing, Sales, Product Development and the Country Manager. Lifecycle planning strategy: Build and implement proactive regulatory strategy to optimise value, reduce risk control costs and ensure compliance. Experience: A self-motivated, driven individual who is engaging with ability to influence a diverse range of stakeholders. Formal tertiary qualifications in Science, Pharmacy, Medicine, or Healthcare. Experience in Regulatory Affairs and Medical Marketing with direct reports. Demonstrated strong leadership capability with proven experience in driving a high performing team and agile culture. Thorough knowledge of the region’s Health Authority Organisations. Prior industry experience in the health science sector e.g. pharmaceuticals, over-the-counter medicines. Excellent interpersonal communication and organisational skills. Ability to thrive in a fast-paced, highly agile workplace. Application: If you are ready for your next challenge and confident you match the required profile; we look forward to receiving your application. For any additional information before applying, please email James at to arrange a convenient time to speak. Thank you. Seniority level Director Employment type Full-time Job function Legal #J-18808-Ljbffr