Manager, International Regulatory Affairs
Company: Horizon Therapeutics
Location: Glenview
Posted on: May 9, 2022
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Job Description:
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.
Position Summary:
The Manager International Regulatory Affairs is responsible to
liaise with cross functional colleagues while representing
Regulatory function to support the submission of marketing
authorization applications for international markets.
Responsibilities:
Builds overall Marketing Application timelines for International
markets Coordinates with cross functional project representatives
in clinical, non-clinical & Regulatory on the creation of
country-specific dossier to ensure timely submissions of Marketing
Applications for international markets Supports the logistical
process and detailed timeline for scientific/regulatory content
creation for commercial, and life-cycle regulatory submissions and
coordinates with cross functional colleagues' responses to health
authority questions Supports dossier creation and system compliance
for regulatory submissions Attends product specific subteam
meetings, international subteam meetings to represent the
regulatory viewpoints and requirements for international markets
Develops and maintains current regulatory knowledge in
countries/regions of interest and advises management of significant
development Works across functions to ensure Module 1 regional
documents preparations are conducted, as needed Ability to travel -
potential to be international as required
Qualifications and Skills Required:
BSc/BA Chemistry, Biochemistry, Biology, or Pharmaceutical Science
Hands on experience (4 years plus) in a global regulatory affairs
position or in a technical functional and has previously
coordinated submissions of Marketing Applications to international
markets Biologics experience is a must Proficient using Regulatory
Information/Quality Systems and managing eCTD submissions Prior
experience with filing of marketing applications, supplements, and
variations for biologic products within timelines is required,
global submission experience is desired. Experience in orphan drugs
is desired A good understanding of IND, CTA, BLA, NDA and MAA
processes Strong knowledge of international GMP quality
regulations, current industry practices, and experience with
interpretation and application to development projects and marketed
product regulatory issues Proficient in Microsoft Office
Professional, proactive demeanor Strong interpersonal skills
Excellent written and verbal communication skills
Horizon Core Values & Competencies:
Growth
Manages Ambiguity Strategic Mindset Demonstrates Self-awareness
Cultivates Innovation Develops Talent
Accountability
Drives Results Ensures Accountability Decision Quality
Transparency
Courage Collaboration Instills Trust
Horizon requires all U.S. employees to be fully vaccinated, as a
condition of employment, with either Pfizer (fully approved by the
U.S. Food and Drug Administration), Moderna or Johnson & Johnson
(currently granted emergency-use authorization by the FDA). "Fully
vaccinated" is defined as two weeks after your final dose of the
Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide
medical and religious accommodations as required by law.
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.
Keywords: Horizon Therapeutics, Glenview , Manager, International Regulatory Affairs, Executive , Glenview, Illinois
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