Director, Regulatory Affairs Operations
Company: Horizon Therapeutics
Posted on: May 23, 2023
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.
- Oversee and monitor global submission management activities,
with particular focus on EU and other International markets in
collaboration with Regulatory submission leads and external
- 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
- Develop, monitor, and refine submission management KPIs on an
ongoing basis in collaboration with Regulatory management
- Lead and mentor the Regulatory technology team and manage all
aspects of Regulatory information management (RIM), including RIM
- Instrumental in identification (and/or development),
integration and implementation of interim/ long-term technology
solutions/ initiatives, in support on evolving regulatory
- 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
- Address Regulatory Reporting and Analytics need using
information available in systems, spreadsheets, and network
- 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
- 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
- In-depth knowledge and experience with EU and International
eCTD/non-eCTD dossiers, submission planning, tracking, and dossier
- 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
- 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
- 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
- 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
- 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
- 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
Keywords: Horizon Therapeutics, Arlington Heights , Director, Regulatory Affairs Operations, Executive , Deerfield, Illinois
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