Regulatory System Support
The Regulatory System Support is responsible to ensure regulatory systems in the EMEA region primarily are maintained and operate effectively. He/she will work within the Regulatory Affairs Operations International – EMEA team, based in Brussels under the supervision of the business process leads for these systems.
The regulatory systems in his/her scope consist of:
The submission planning and execution systems, a suite of tools mainly based on MS Project and Appian. These systems support the regulatory submission planning activities of our organization.
He/she will support and work in close collaboration with his key stakeholders:
• Regulatory teams in the EMEA region primarily;
• HQ business system owners (Regulatory systems)
• Support process development, maintenance and improvement projects that ensure system performance and enabling new capabilities
• Provide daily support that consist of managing end-user access, addressing queries and problems and support their resolution. Qualify the issues to be escalated to different levels of support teams.
• Maintain a knowledge base of issues and resolutions
Minimum Bachelor’s Degree, preferably in IT, with a minimum of 2 years of pharmaceutical experience, preferably within the Regulatory area
Experience with the following tools/systems:
• MS Project : good to excellent knowledge required
• Office 365 : mostly MS Excel (pivot tables and graphs)
• Sharepoint 365:
• knowledge of JIRA is a plus
Business systems support skills:
• Knowledge of HelpDesk and Service Delivery tools and environment
• Experience with defining/improving operational procedures.
• Project Management Skills
• Process Management Knowledge
• Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines, in a matrix environment
• Excellent technical documentation skills
• Proficiency with diagramming software: MS Visio
• Well organized, highly motivated process and results driven
• Excellent presentation, facilitation and communication skills, both written and oral, in English
• Flexible, pro-active and a team player
What we offer
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
- Nijverheidslaan 3, - Strombeek-Bever