Director, International Regulatory Affairs
Company: Horizon Therapeutics plc
Posted on: February 15, 2021
Director, International Regulatory Affairs Working at Horizon is
more than a job - it's personal. For us, success is measured by the
numbers that matter most - the number of lives we touch, the number
we change and those we work tirelessly to help save. We're a team
of agile, out-of-the-box thinkers who are inspired to do more
because we know we're a part of something bigger. We strive to
build meaningful careers at a company whose values we share because
when we live up to our potential, we help others live up to theirs.
Responsibilities; The Director International Regulatory Affairs, is
responsible for developing and implementing international
regulatory strategies to secure and maintain market approval for
marketed and development stage medicines. Leads the international
regulatory strategy within the cross-functional teams. Proactively
anticipates and mitigates regulatory risks. Ensures compliance with
international regulatory requirements. Demonstrates an
understanding of drug development and leadership behaviors
consistent with level. Develops and implements acceleration
strategies. May have direct reports.
- Responsible for developing international regulatory strategies
across Horizon's portfolio of medicines
- Drives the tactical implementation of strategic regulatory
plans for the creation and submission of regulatory documents, e.g.
CTAs, Marketing Applications, and other relevant regulatory
- Leads a team of international regulatory professionals for
development and marketed products.
- Influences the development of regulations and guidance. Advises
management of the effect of current or proposed laws, regulations,
guidelines, and standards, etc.
- Effectively manage multiple projects and responsibilities
- Ability to thrive in a fast-paced innovative environment while
remaining flexible, proactive, resourceful and efficient are
- Ability to integrate cross-functional issues and balance
competing priorities effectively
- Proven ability to communicate clearly and present key
information objectively and collaborate effectively with
- Demonstrated ability to clearly and concisely communicate/
prepare presentations for all levels of management from executive
to manager level. Qualifications and Required Skills;
- Bachelor's degree in life sciences (pharmacy, biology,
chemistry, pharmacology) or a related subject.
- 10+ years of International Regulatory experience in the
- Experience as a lead regulatory product strategist in two or
more major regions such as EU or Japan.
- Demonstrated experience leading and motivating cross-functional
teams and managing direct reports
- Outstanding leadership skills including excellent verbal and
written communication skills, an innovative approach to
problem-solving, and an integrated view of business and scientific
-- Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Develops Talent Accountability
- Drives Results
- Ensures Accountability
- Decision Quality Transparency
- Courage Horizon Therapeutics plc does not discriminate on the
basis of race, color, religion, gender, sexual orientation,
national origin, age, disability, veteran status, or any other
characteristic protected by law. It is our intention that all
qualified applications are given equal opportunity and that
selection decisions be based on job-related factors. Any
individual, who, because of a disability, needs accommodation or
assistance in completing this application or at any time during the
application process, should contact the Human Resources Department.
Posted 3 Days Ago Full time R0002338 About Us Horizon is focused on
researching, developing and commercializing medicines that address
critical needs for people impacted by rare and rheumatic diseases.
Our pipeline is purposeful: we apply scientific expertise and
courage to bring clinically meaningful therapies to patients. We
believe science and compassion must work together to transform
lives. For more information on how we go to incredible lengths to
impact lives, please visit www.horizontherapeutics.com and follow
us on Twitter , LinkedIn , Instagram and Facebook .
Keywords: Horizon Therapeutics plc, Arlington Heights , Director, International Regulatory Affairs, Executive , Deerfield, Illinois
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