Director, Global Regulatory Affairs
Posted on: October 19, 2020
Regulatory Affairs Director
Feel valued for your influential work in shaping drug development
and gaining fast, efficient approvals. We are pro-actively involved
in the strategy, changing the course for approvals and influencing
regulators on new technology. Without us, our ground-breaking
science wouldnt have half the impact.
At AstraZeneca, we put patients first and strive to meet their
unmet needs worldwide. Working here means being results-oriented
thinking big and working together to make the impossible a reality.
If you are swift to action, confident to lead, willing to
collaborate, and curious about what science can do, then youre our
kind of person.
AstraZenecas pipeline of innovative medicines is consistently
growing within both Cardiovascular, Renal and Metabolism (CVRM) and
Respiratory and Immunology (R&I) two of our major therapy
areas. To meet the increasing demand of regulatory expertise, we
continue to expand our regulatory functions through the recruitment
of strategically focused Regulatory Affairs professionals . With
us, you will get the opportunity to work across the spectrum of
drug development to progress a rich and diverse pipeline of both
small and big molecules. You will work across multiple therapy
areas in an atmosphere of collaboration and inclusion where
Regulatory Affairs is a respected voice and considered an equal
partner in the business.
We continue to expand our regulatory teams at AstraZenecas dynamic
R&D sites in Gothenburg, Sweden, Cambridge, UK, Gaithersburg,
US and Durham, US. If you are looking for a new challenge, we are
offering opportunities in different disease areas and at different
levels, depending on your expertise and previous experience.Main
duties and responsibilitiesAs a Regulatory Affairs professional
within AstraZeneca, you will play a key role in channelling 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.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 organisation.
- 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
- Successful leadership to at least one major regulatory approval
at a global level is required for senior positions.
- 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 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 recognising their potential. Join us on our journey of building
a new kind of organisation to reset expectations of what a
bio-pharmaceutical company can be. This means were opening new ways
to work, pioneering groundbreaking methods and bringing unexpected
teams together. Interested? Come and join our journey.
We are eager to know more about you. If you are interested to know
more about us, apply now!
We welcome your application no later than 30th October 2020.
Please apply as soon as possible as we will be continuously
screening and interviewing candidates. Thank You!
We are an equal opportunity employer and value diversity at our
company. We do not discriminate on the basis of race, religion,
color, national origin, sex, gender, gender expression, sexual
orientation, age, marital status, veteran status, or disability
status. We will ensure that individuals with disabilities are
provided reasonable accommodation to participate in the job
application or interview process, to perform essential job
functions, and to receive other benefits and privileges of
employment. Please contact us to request accommodation.
Keywords: AstraZeneca, Washington DC , Director, Global Regulatory Affairs, Executive , Gaithersburg, DC
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