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Manager, International Regulatory Affairs

Company: Horizon Therapeutics
Location: Mount Prospect
Posted on: May 14, 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 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, Mount Prospect , Manager, International Regulatory Affairs, Executive , Mount Prospect, Illinois

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