FSP Regulatory Affairs Consultant - CTR (flexible location UK/EU)

We are currently looking for a Regulatory Affairs Professionals to join one of our clients and act as a (Senior) Regulatory Affairs Consultant CTR.

This role can be based in either UK or UE (home/office based) and we have flexibility on levels.

In this role you will work closely with other departments to design, implement applications & systems to support regulatory business processes. You will work with key stakeholders to map current processes and organize task forces to define and implement process improvements. You will support the organization by analyzing (as business analyst) and managing and/or coordinating EU CTR process changes and organizational changes.

Role responsibilities:

Draw models for the business processes (process flows)

Moderate workshops with business experts

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 implementation

Write & run user test cases

Provide support to end-users

Design and generate reports for stakeholders

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)

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.

• Project Management experience

• 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.

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