Unicon Pharma Inc
Location
Gaithersburg, MD | United States
Job description
Description:
Director Regulatory Affairs, Late Cardiovascular, Renal and Metabolism
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 client products across the portfolio!
Client's pipeline of innovative medicines is consistently growing within Cardiovascular, Renal and Metabolism (CVRM). Within CVRM Regulatory Affairs they take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it working across clients early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, they are focused and committed to the development of their products as well as to their people providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.
What You'll do
As a Regulatory Affairs professional within client, you will play a key role in channelling thei scientific capabilities to make a positive impact on changing patients' lives. In Regulatory Affairs, their teams influence the development of client innovative pipeline, define the regulatory strategy for their therapeutic assets, and engage with Health Authorities to effectively inform client development programs. In this way, Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world.
Strategic thinking is key within their 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.
Academic degree in a science related field or equivalent
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.
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