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Regulatory Affairs Professional - CTR Project Manager client dedicated (flexible location EU/UK)

United Kingdom, Remote Date posted 08/19/2022 Job ID R0000001576

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant


  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.


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

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.


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