Director, Global Regulatory Affairs, Product Strategy

Company: Horizon Therapeutics
Location: Evanston
Posted on: March 19, 2023

Job Description:

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 Global 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.Formulates regulatory strategies to optimize regulatory timings, competitive positioning and opportunities.Presents regulatory strategies to internal governance bodies. Influences internal and external customers as necessary to ensure successful strategy implementation.Manages regulatory agency 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.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 professionMentors, develops, and assesses direct reports including monitoring and managing workload and assignmentsQualifications 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 plusDemonstrated ability to work and draft documents in a fast-paced environmentFlexible with respect to prioritization of daily tasks and projects according to internal and external influencesProficient in Microsoft Office.Professional, proactive demeanor.Strong organizational skills and attention to detailExcellent written and verbal communication skillsLeadership capabilities working across varied cultures, expertise and backgrounds.Our ValuesTransparency: 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 employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of workingDevelop 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.

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