Regulatory Affairs Director

Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio! About Company At Company, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Cardiovascular, Renal & Metabolism - Regulatory Science and Strategy Company’s pipeline of innovative medicines is consistently growing within Cardiovascular, Renal & Metabolism (CVRM). To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists. With us, you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes. What you’ll do As a Regulatory Affairs professional within Company, you will play a key role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world. Strategic thinking is key within our function. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. Essential for the Role: Advanced Degree in Life Science or related discipline. 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization. Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development Proven track record of regulatory drug development including product approval/launch. Experience in leading Major Health Authority interactions Ability to think strategically and critically and evaluate risks to regulatory activities. Ability to work strategically within a complex, business critical and high-profile development program. #J-18808-Ljbffr Zenith LifeScience