Director, International Regulatory Affairs

Company: Horizon Therapeutics plc
Location: Deerfield
Posted on: February 15, 2021

Job Description:

Director, International Regulatory Affairs 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. Responsibilities; The Director International Regulatory Affairs, is responsible for developing and implementing international regulatory strategies to secure and maintain market approval for marketed and development stage medicines. Leads the international regulatory strategy within the cross-functional teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with international regulatory requirements. Demonstrates an understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. May have direct reports.

• Responsible for developing international regulatory strategies across Horizon's portfolio of medicines
• Drives the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g. CTAs, Marketing Applications, and other relevant regulatory filings.
• Leads a team of international regulatory professionals for development and marketed products.
• Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines, and standards, etc.
• Effectively manage multiple projects and responsibilities concurrently
• Ability to thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient are essential.
• Ability to integrate cross-functional issues and balance competing priorities effectively
• Proven ability to communicate clearly and present key information objectively and collaborate effectively with management.
• Demonstrated ability to clearly and concisely communicate/ prepare presentations for all levels of management from executive to manager level. Qualifications and Required Skills;
  • Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or a related subject.
  • 10+ years of International Regulatory experience in the Biotech/Pharmaceutical industry
  • Experience as a lead regulatory product strategist in two or more major regions such as EU or Japan.
  • Demonstrated experience leading and motivating cross-functional teams and managing direct reports
  • Outstanding leadership skills including excellent verbal and written communication skills, an innovative approach to problem-solving, and an integrated view of business and scientific issues.
    -- Horizon Core Values & Competencies:
    -- Growth
    • Manages Ambiguity
    • Strategic Mindset
    • Demonstrates Self-awareness
    • Develops Talent Accountability
      • Drives Results
      • Ensures Accountability
      • Decision Quality Transparency
        • Courage 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. Posted 3 Days Ago Full time R0002338 About Us Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter , LinkedIn , Instagram and Facebook .

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