Regulatory Affairs IT Specialist

3 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000
Regulatory Affairs IT Specialist

We're looking for a skilled Regulatory Affairs IT Specialist to join our team. This role involves overseeing the development and implementation of IT solutions that support regulatory compliance across various industries, including pharmaceutical manufacturing, hospitals and healthcare, and biotechnology research.

About The Job

This is an exciting opportunity for a mid-senior level professional with a strong background in life science technology and experience in IT strategy development, solution design, project delivery, and service management. The ideal candidate will have a good understanding of RIM functional processes, such as registrations management, submission planning, submission content planning, document management, publishing, and regulatory business processes.

  • Develop and implement IT solutions to ensure regulatory compliance
  • Partner with internal stakeholders to drive innovation and improve existing processes
  • Ensure all IT products are compliant with internal security, risk management policies, and external regulatory requirements
  • Orchestrate the stage gate/demand process to bring ideas to new IT solutions
  • Guide a product-oriented IT team that owns end-to-end GRA IT solutions
  • Act as program manager and ensure excellence in project set-up and execution
  • Ensure end-to-end availability and quality of GRA Solution Services
  • Communicate/reporting of R&D IT projects/Solution Services to relevant stakeholders
About You

To succeed in this role, you'll need:

  • A minimum of 8 years' experience working in a life science technology environment, preferably in scientific technology
  • A Master's degree or equivalent experience in science, engineering, computing, bioinformatics, or a related field
  • Strong analytical, organizational, communication, and presentation skills at a senior level
  • Excellent problem-solving and collaboration skills
  • Fluent in business English; German is a plus
Benefits

This is a full-time position offering competitive benefits and opportunities for career growth and development.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Legal, Business Development, and Information Technology
Industries
  • Pharmaceutical Manufacturing
  • Hospitals and Healthcare
  • Biotechnology Research

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