Heron Therapeutics develops cutting-edge medicine to meet unmet patient needs and solve big problems by applying our innovative science and technologies with well-known pharmacology. With therapeutic areas in Oncology and Acute Care, our goal is to offer alternatives so patients can be opioid-free post-surgery. With additional products and indications on their way, we are excited to be growing and adding to our amazing team. Our entrepreneurial culture gives everyone the chance to be heard with easy access to decision-makers like other smaller companies, along with some of the sophistication and benefits of larger organizations. We developed the Heron Ways of Working to implement training and practices that breathe life into our values and embed them into our daily experience such as open collaboration across teams, self-responsibility & accountability, communication strategies & techniques, and the mindset of always assuming positive intent! The Director, Regulatory Affairs is responsible for global regulatory affairs strategy and management of assigned projects covering the development, registration and post approval phases, and acts as liaison with the health authorities including the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) review divisions and Office of Prescription Drug Promotion (OPDP), European Medicines Agency (EMA), and other regulatory authorities as appropriate. Works closely with other functional areas to develop regulatory strategies and timelines, including regulatory operations, development, pharmacovigilance, legal, marketing, sales operations, and medical affairs.
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