Director of Regulatory Affairs (LC 27775)

What You’ll do
As a Regulatory Affairs professional within Company, 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.

• 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.

At Company when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be.
This means we’re opening new ways to work, pioneering ground breaking methods and bringing unexpected teams together. Interested? Come and join our journey.

Job Types: Full-time, Contract

Salary: $135.00 - $150.00 per hour

Benefits:

• Dental insurance
• Health insurance

Experience level:

• 8 years

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Gaithersburg, MD 20878: Relocate before starting work (Required)

Work Location: In person