Director, Regulatory Affairs Operations

Company: Horizon Therapeutics
Location: Deerfield
Posted on: May 23, 2023

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. Position Summary: The Director of Regulatory Operations is responsible for overseeing and/or directly managing EU and International submission management activities/projects, global Regulatory systems, and data in coordination with IT, in-house resources, or vendors. This role will actively support the execution and implementation of operational strategies, priorities, and goals in alignment with Regulatory leadership and cross-functional stakeholders. Routine communication with key business stakeholders and clear management of expectations is expected of this role. The Director will partner with relevant functions to develop, maintain, modify, and implement agile business processes taking into consideration the need to utilize both internal and external resources, and effective use of electronic systems and tools within Horizon. This role will ensure regulatory submissions and systems compliance, as required by health agencies and internal company procedures or policies. Responsibilities:

• Oversee and monitor global submission management activities, with particular focus on EU and other International markets in collaboration with Regulatory submission leads and external vendors.
• Implement and/or utilize project management, planning and tracking tools to ensure all submissions are planned, coordinated, and delivered on time, adhering to company and agency standards.
• Develop, monitor, and refine submission management KPIs on an ongoing basis in collaboration with Regulatory management team.
• Lead and mentor the Regulatory technology team and manage all aspects of Regulatory information management (RIM), including RIM governance.
• Instrumental in identification (and/or development), integration and implementation of interim/ long-term technology solutions/ initiatives, in support on evolving regulatory needs.
• Develop and/or refine the RIM master data in collaboration with key stakeholders, and in alignment with emerging health authority requirements or electronic standards.
• Manage access to and use of health agency submission portals (e.g., FDA, EMA, HC etc.) including product/ sponsor data, business process and training.
• Actively support due-diligence, integration, or key compliance activities, including audits and inspections.
• Responsible for projecting timeline, resource and budget for integration, or information migration or solution implementation.
• Address Regulatory Reporting and Analytics need using information available in systems, spreadsheets, and network shares.
• Utilize opportunities for tactically utilizing emerging technology (e.g., AI, machine learning, NLP) in enhancing compliance, efficiency, and reporting.
• Help develop, improve, and implement internal business processes (e.g., SOP, WI, Job-aid) for RIM data and submission standards.
• Provide oversight and/or assist in developing training framework, materials, and execution.
• Maintain familiarity with current and future global regulatory submission standards. Qualifications and Skills Required:
  • Bachelor's degree or equivalent in life sciences or technology-related discipline. Advanced degree a plus.
  • 8+ years' experience in Regulatory Affairs or Regulatory Operations or IT supporting Regulatory submissions and systems.
  • In-depth knowledge and experience with EU and International eCTD/non-eCTD dossiers, submission planning, tracking, and dossier management.
  • Proven knowledge of directly managing submissions and product information using EMA systems (IRIS, SPOR, xEVMPD, CTIS, CESP, eAF and emerging IDMP standard).
  • Sound understanding of submission requirements and RIM.
  • Experience with cross-functional system implementation, training, and support.
  • Experience supporting validated regulatory systems including Veeva Vault RIM document management and publishing applications, and other tools used for regulatory submissions.
  • Proficiency with Computer Systems Validation process and related compliance concepts
  • Good communication, listening, and negotiation skills.
  • Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
  • Strong people management, interpersonal, communications and presentation skills.
  • Demonstrated ability to work in a fast-paced environment
  • Flexible with respect to prioritization of daily tasks and projects according to internal and external influences.
  • Staff management experience is required.
  • Proficient in Microsoft Office.
  • Strong organizational skills and attention to detail.Technical Skills:
    • Proficient in Microsoft Office Suite including, but not limited to: Word, Excel, PowerPoint, Visio; Adobe Acrobat; ISI Toolbox; enterprise class electronic document management systems (preferably Veeva Vault RIM); publishing software (preferably Veeva Vault RIM Submission Publishing). Ability to quickly learn new technology, adapt and apply to business needs.Our Values
      • Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
      • Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
      • Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employees
        • Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
        • Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
        • Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
        • Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
        • Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleCompensation and Benefits Summary:The salary range for this role is $193,500.00-$236,500.00 annually. The base salary offered may vary based on the final candidate's qualifications. The level of this role may also change based on the final candidate's qualifications.In addition to the salary, this position is eligible for the benefits listed here and for the following plans:Salary Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity Grant, Corporate BonusAt Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Arlington Heights , Director, Regulatory Affairs Operations, Executive , Deerfield, Illinois