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Director Reg Drug Proj Del

Axelon Services Corporation

Posted on: 09 Mar 2024

Job Location: Gaithersburg, US

Job Description:

Director Reg Drug Proj Del

Gaithersburg,MD

6 Months

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 our products across the portfolio!

Client s pipeline of innovative medicines is consistently growing within Cardiovascular, Renal and Metabolism (CVRM). Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we re focused and committed to the development of our products as well as to our people providing an open and supportive space to explore, learn and develop across all regulatory roles

and levels.

We are more than 65.000 people in over 100 countries. Our aim is simple to positively impact lives together.

Using the power of science and innovation, our people improve the impact medicine has on patients.

Together, we explore the world of science through our remarkable product pipeline and we take our understanding of the CVRM therapeutic area to a whole new level by seeking new treatments.

What You ll do

As a Regulatory Affairs professional within Client, 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 Client 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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