Director, Regulatory Affairs Operations & Systems

05 Sep, 2022

Jobs

Director, Regulatory Affairs Operations & Systems

Horizon Therapeutics
Rockville, MD

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 Operations and Systems is responsible for directing and over-seeing all activities of the Regulatory Operations and Regulatory Systems groups. As a member of the Regulatory leadership team, the Director will be responsible for communicating and aligning on Regulatory priorities. This role will be responsible for defining and implementing the strategic vision company-wide for expansion of Horizon’s Regulatory Information Management (RIM) and publishing systems to support globalization efforts. Additional responsibilities include: overseeing health authority submissions, managing internal and external publishing staff, and overseeing regulatory compliance activities, as assigned.

 

Responsibilities:

  • Lead regulatory technology projects and establish project times. This includes leading the implementation, validation, training and operation of electronic document management/RIM systems (Veeva), eCTD and other publishing and Regulatory technology projects.
  • Establish and implement efficient, standardized best practices for global regulatory submissions.
  • Build and manage relationships with key stakeholders in other parts of the organization, in the industry and in the profession
  • Demonstrate leadership, problem-solving ability, flexibility, and teamwork
  • Identify, prioritize, and resolve issues of critical importance; provide sound regulatory advice and make informed decisions on complex issues
  • Exercise good judgement in elevating and communicating actual or potential issues to line management
  • Mentors, develops, and assesses direct reports including monitoring and managing workload and assignments
  • Provides interpretative analyses of complex regulatory guidance documents, regulations, or directives that impact the company’s products and operations.
  • Contributes to and manages the Regulatory Operations budget

 

 

Qualifications and Skills Required:

  • Bachelor’s degree or equivalent in life sciences or technology-related discipline. Advanced degree a plus.
  • 10+ years previous biotechnology and/or pharmaceutical drug development experience.
  • Experience with cross-functional system implementation, training, and maintenance.
  • Demonstrated ability to think cross-functionally with regards to impact across and beyond Regulatory Affairs.
  • 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 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.
  • 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.

 

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 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.

Learn more here

Job posted: 2022-09-05