Manager, International Regulatory Affairs
Company: Horizon Therapeutics
Location: Deerfield
Posted on: May 13, 2022
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
requiredQualifications 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 skillsHorizon 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, Arlington Heights , Manager, International Regulatory Affairs, Executive , Deerfield, Illinois
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