Senior Regulatory Affairs Consultant - EU CTR Project Manager

We are currently looking for a (Senior) Regulatory Affairs Consultant to join one of our clients and act as EU CTR Submission Project Manager for Regulatory Affairs in Development Delivery.

In this role you will work closely with IT Project Manager to design, implement applications & systems to support regulatory business processes. This includes the analysis of the demand, the realization of the application through customization/development and testing. You will work with key stakeholders to map current processes and organize task forces to define and implement process improvements. You will develop documentation and training package and support activities (response to questions from users). You will support the organization by analyzing (as business analyst) and managing and/or coordinating EU CTR process changes and organizational changes. You may also deliver project management, compliance and regulatory intelligence in the framework of Clinical Trial Applications (CTA) as per the new EU CT Regulation and the former EU CT directive.

Role responsibilities: Draw models for the business processes (process flows) Moderate workshops with business experts Capture the User Requirements Formally document User Requirements Coordinate analysis and activities with IT Project Manager Ensure good communication with stakeholders in the project (verbally and written) Draft new procedures based on new business processes & user requirements Create training material and reference guides Evaluate new system packages for implementaion Write & run user test cases Provide support to end-users Design and generate reports for stakeholders Design and maintain KPIs on system data Design and QC metrics to monitor system data quality Liaise with other operational teams for system inter-operability Work with external partners and authorities for data update and data exchange with authorities (e.g. EMA for XEVMPD, IDMP) Qualifications

Ideal candidate will possess:

• University degree in a science discipline

• A background in clinical trial management with a specific focus on EU CTR

• Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization , and training.

• Minimum 5 years’ experience as Project Manager

IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI…)

• Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.

• Customer-oriented and autonomous

• Fluency in English is a must along with the local language.