Regulatory Affairs Director - CRVM

Job Description

What Youll do As a Regulatory Affairs professional within Organization, you will play a key role in channeling 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 In combination with your regulatory expertise, successful candidates will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. It is important that you embrace the concepts of novel regulatory tools and technology as well as a culture of sharing experiences with others so that the medicines that we develop will benefit from latest approaches in regulatory science. You are comfortable speaking the regulatory voice at all levels of the organization. Bachelors degree in a science related field. 3+ 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.