Regulatory Clinical Trial Application Submission Manager

For one of our clients located in the East of Brussels, we are looking for a Regulatory Clinical Trial Application Submission Manager.

  • Do you have a University Degree in Life Sciences?
  • Do you have at least 5 years of experience in an international clinical trial regulatory environment within a management position?
  • Are you fluent in English (oral and written)?

Then you might be the candidate we are looking for. Don't hesitate and apply now!

Job Description 

As a Regulatory Clinical Trial Application Submission Manager, you work under the supervision of the Head of the Department. You are involved in the management of the Regulatory Affairs Department for workload planning and staff coaching throughout the whole life cycle of the clinical trial applications across Europe.

Responsibilities 
  • You are the first entry port for any new project that requires regulatory advice during the planning phase.
  • You provide ongoing updates on changes in the regulatory environment
  • You advise on and review regulatory documents to ensure compliance with applicable regulations and propose actions if required
  • You ensure together with the Head of Department, initial and continuous training as well as personal development & regulatory advice to all members of the RA Department
  • You support the Head of Department in the development of procedures and templates
  • You act as the Back up of the Head of Department at relevant meetings (General team meetings, external meetings, ...)
Profile 
  • You have a University Degree in Life Sciences.
  • You have at least 5 years of relevant experience in an international clinical trial regulatory environment from a sponsor perspective in a management/decision-making position.
  • You have a good knowledge of current and future EU regulatory environment.
  • You have the ability to coordinate work transversally with other departments, to reach deliverables by deadlines.
  • You have experience in QC of regulatory submission documents.
  • You have experience in team management and you are familiar with project management tools for planning.
  • You have good organization skills and you are multi-tasking.
  • You have excellent written and verbal English skills.
Contact Information 

Amandine Planche
+32 10 68 53 30
amandine.planche@valesta.com

Application form : Regulatory Clinical Trial Application Submission Manager

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

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