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Senior Regulatory Affairs Associate (Czech Republic, Prague)

Prague, Hlavní město Praha, Czechia Date posted 09/12/2021 Job ID 72263BR

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.


Senior Regulatory Affairs Associate
- acting as a local regulatory contact representing various MAH's in Slovakia and/or Czech Republic, esp. covering all MA's related maintenance activities
- acting as a local regulatory contact for clinical trials in the Czech Republic, Slovakia and Canada
• Preparation and quality control of core regulatory submission packages, preparation and quality control of local regulatory submission packages for submissions to RA's in the Czech Republic, Slovakia and Canada to ensure regulatory compliance, accuracy and completeness. Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions.
• Interacting with Czech, Slovak and Canadian regulatory authorities, as required; liaise with internal and external partners on assigned projects, provide internal and external regulatory consultancy.
• Preparation, review and approval of labels. Later when he/she get more experience/familiar with our processes to act as RL or RAL coordinating the CTA and/or MAA.
• Global Regulatory Lead for clinical trial applications coordinating regulatory activities on international multi-center trials (design, plan and schedule activities and deliverables; interact with client and project team), support and development of submission plans and strategy to regulatory authorities, oversight and support for response management. And mentor junior colleagues and performing trainings and support for submissions in the 3 countries.


Ideally, the candidate should be Czech or Slovak native with university education in the natural sciences (biochemistry, biotechnology, pharmacist) and at least 2 years experience in the regulatory affairs area - CTA and/or MAA.

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