Director, Global Regulatory Affairs, Product Strategy
Company: Horizon Therapeutics
Location: Evanston
Posted on: March 19, 2023
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Job Description:
Job Description:
At Horizon Therapeutics, we define success by the number of lives
touched, lives changed, and lives saved. Our global biotechnology
company is made up of agile, out-of-the-box thinkers with a focus
on delivering breakthrough medicines to those living with rare,
autoimmune, and severe inflammatory diseases. This is the heart of
our global mission. Start a career that enables you to live up to
your potential and help others live up to theirs. Join us. The
exceptional support we provide patients and communities equally
extends to our employees. We offer industry-leading and
award-winning benefits, compensation and rewards programs that
positively impact all areas of our employees' personal and
professional lives. Position Summary: The Director of Global
Regulatory Affairs is responsible for leading both the strategic
and operational aspects of Regulatory Affairs objectives for
products marketed in the U.S., E.U., and rest-of-the-world (ROW) as
well as development stage products. This position is also
responsible for coordinating all aspects of regulatory submissions
for assigned projects, providing guidance on post-approval changes,
developing regulatory strategy, and representing the function on
cross-functional teams. Responsibilities:Provides regulatory
leadership to cross-functional teams, ensuring cross-functional
perspective/expertise is incorporated in regulatory plans prior to
decisions being made.Formulates regulatory strategies to optimize
regulatory timings, competitive positioning and
opportunities.Presents regulatory strategies to internal governance
bodies. Influences internal and external customers as necessary to
ensure successful strategy implementation.Manages regulatory agency
liaisons responsible for regulatory strategy, tactics and direction
to product development in preparation of submission documents,
responses to queries by regulatory agencies.Directs the team in
developing, implementing and delivering a regulatory strategy for
highly complex products which balance time, cost, quality and risk
which meets the needs of Horizon. Drives regulatory aspects of
marketed product life cycle management including critical issue
management and major line extensions.Manages the preparation and
timely submission of regulatory documents.Provides interpretative
analyses of complex regulatory guidance documents, regulations, or
directives that impact the company's products and
operations.Ensures quality and compliance of regulatory activities
by adhering to established corporate and functional processes,
guidelines and SOP's.Cultivates relationships with key colleagues
in other parts of the organization, in the industry and in the
professionMentors, develops, and assesses direct reports including
monitoring and managing workload and assignmentsQualifications and
Skills Required:Bachelor's degree in Life Sciences, Chemistry or
Biology. Advanced degree a plus.15 years previous biotechnology
and/or pharmaceutical drug development experience.12 years
regulatory affairs experience involving direct contact with
regulatory agencies; full knowledge of FDA, EU & ICH regulations
and guidelines, and the ability to provide interpretations of the
information to others.Solid understanding of dossier requirements
New Drug Application (NDA), Marketing Authorization Application
(MAA) and Clinical Trial Authorization (IND, IMPD, CTA) and ability
to strategically interpret and respond to requests from regulatory
agencies.Ability to work with high level contacts and exposure to
sensitive information necessitating considerable use of tact,
diplomacy, discretion and judgment.Preferred knowledge and
experience with the regulatory process for approval of both
biologics and small molecule products, combination product
experience a plusDemonstrated ability to work and draft documents
in a fast-paced environmentFlexible with respect to prioritization
of daily tasks and projects according to internal and external
influencesProficient in Microsoft Office.Professional, proactive
demeanor.Strong organizational skills and attention to
detailExcellent written and verbal communication skillsLeadership
capabilities working across varied cultures, expertise and
backgrounds.Our ValuesTransparency: We value collaboration.
Trusting teach other and tackling tough challenges can make a
powerful difference.Accountability: We do what's right for our
patient communities through quality decisions and owning our
successes and failures.Growth: We fiercely innovate and evolve to
better ourselves, our communities and our patients.These three
values come to life through our five Leadership Expectations that
apply to all Horizon employeesEnterprise Mindset: Look beyond one's
team, brand or function to see the broader company and external
perspectiveExhibit Intellectual Curiosity: Seek to understand what
you do not know; ask the right questions of the right people and
sourcesEnsure Accountability and Courage: Step up to address
difficult issues and hold self and others accountable to
commitmentsEmbrace Diverse Perspectives: Welcome others with a
respectful attitude; integrate diverse perspectives into ways of
workingDevelop Talent: Provide feedback, coaching and mentorship to
help others be more effective in their roleCompensation and
Benefits Summary:The salary range for this role is
$193,500.00-$236,500.00 annually. The base salary offered may vary
based on the final candidate's qualifications. The level of this
role may also change based on the final candidate's
qualifications.In addition to the salary, this position is eligible
for the benefits listed here and for the following plans:Salary
Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity
Grant, Corporate BonusAt Horizon, we know that disease does not
discriminate. We embrace the bold ideas of one another, foster a
sense of belonging, and value inclusion. We attract and develop
diverse talent because we believe that when people from different
backgrounds and life experiences come together, we make lives
better. Horizon intends that all qualified applications are given
equal opportunity, and that selection decisions be based on
job-related factors. We do not discriminate based on race, color,
religion, gender, sexual orientation, national origin, age,
disability, veteran status, or any other characteristics protected
by law.
Keywords: Horizon Therapeutics, Evanston , Director, Global Regulatory Affairs, Product Strategy, Executive , Evanston, Illinois
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