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Director, Regulatory Affairs

Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: August 5, 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 Director of 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.
  • Assists in the formulation of regulatory strategies to optimize regulatory timings, competitive positioning and opportunities.
  • Manages Health Authority 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.
  • Presents regulatory strategies to internal governance bodies. Influences internal and external customers as necessary to ensure successful strategy implementation.
  • 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 profession
  • Mentors, develops, and assesses direct reports including monitoring and managing workload and assignments

    Qualifications 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 plus
    • Demonstrated ability to work and draft documents in a fast-paced environment
    • Flexible with respect to prioritization of daily tasks and projects according to internal and external influences
    • Proficient in Microsoft Office.
    • Professional, proactive demeanor.
    • Strong organizational skills and attention to detail
    • Excellent written and verbal communication skills
    • Leadership capabilities working across varied cultures, expertise and backgrounds.
      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.by Jobble

Keywords: Horizon Therapeutics, Buffalo Grove , Director, Regulatory Affairs, Executive , Buffalo Grove, Illinois

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