Senior Director & Team Leader - Global Regulatory Affairs, Late R&I
AstraZeneca

Durham, Kansas


Senior Director & Team Leader - Global Regulatory Affairs, Late R&I

Job Description Summary

Provides strategic regulatory leadership to the development, commercialization and life cycle management of the assigned product(s) in product/franchise teams. Applies knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes. Responsible for skill development, performance management, resource allocation at the project or franchise level.

Do you have expertise in, and a passion for Regulatory Affairs? Would you like to apply your expertise in designing unique regulatory strategies and applying innovative methods to impact the development of new medicines for the treatment of Respiratory and Immunology diseases? Do you also have a desire to find efficiencies in submission processes to enable medicines to patients faster and have a vision for submissions of the future? Then this position might be the one for you!

We continue to expand our regulatory teams at AstraZeneca's dynamic R&D sites in Gaithersburg and Durham (US), Gothenburg (Sweden) and Cambridge (UK).

This role seeks a Regulatory Affairs professional with extensive experience in providing strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products and will harness that knowledge to interrogate ongoing programs with an emphasis on incorporating innovative strategies to accelerate medicines to patients. This role is also seeking an individual able to operate above brand, to identify end-to-end acceleration opportunities and identify key opportunities for continuous improvement, striving to be the industry leader in submission excellence.

To be considered for the Senior Regulatory Affairs Director role, candidates should be recognized as an expert in Regulatory Affairs and have a proven track record of driving unique regulatory strategies, innovation, and accelerating and transforming key processes.

Main Duties and Responsibilities

As a Regulatory Affairs professional within AstraZeneca, 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 role, you will support teams in transforming exciting science into valued new medicines for patients around the world, applying innovation and best principles to accelerate the development program. This individual must have strong leadership skills and the ability to influence project teams as well as senior leaders on their innovative recommendations for a program. They must also apply their innovation prowess to our regulatory process, primarily around submission compilation and execution, in designing ways to become the industry leader in regulatory filings.

Key relationships include other Late R&I GRLs to partner with in assessing ideas as well as cross- Regulatory Therapy Area interactions to establish and maintain consistency in submission processes. Other cross-functional relationships are a must (i.e. Clinical Operations, Clinical Development, Statistics) to collaborate on innovative ideas for a project or find efficiencies in our processes.

Requirements

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.

  • Bachelor's Degree in Life Science or related discipline, advanced degree (PharmD, PhD, MBA) a plus.
  • Extensive knowledge of global regulatory affairs within one or more therapeutic areas in early and late development. Prior experience in respiratory or immunology medicines preferred
  • Proven track record of regulatory drug development including successful leadership of at least one major global regulatory filing campaign through to product approval/launch..
  • Current or prior people leadership experience preferred
  • Demonstrable 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.
  • Ability to develop and impart innovative ideas on the drug development process
  • Ability to critique, identify areas for improvement, and implement efficiencies in submission processes.
  • Ability to lead initiatives with cross-functional teams, working with change management to track progress and provide routine updates to management.

At AstraZeneca 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 groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what's next!

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. We will review the applications continuously so please apply as soon as possible.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.



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