Kelly Services
Location
Gaithersburg, MD | United States
Job description
Kelly is hiring for a Director Regulatory Affairs position with one of our clients in Gaithersburg, MD.
Full time- W2
$75/hour
:
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! Our 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, were 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 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
Qualifications and Education Requirements:
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
Important information: This position is recruited for by a remote Kelly office , not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online to be considered for the position.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. That’s why we’re proud to offer a complete array of voluntary benefits to members of the Kelly talent community.
Apply Today!
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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