Regulatory Operations Officer - Mechelen

Job description

The regulatory operations function is responsible for the day-to-day operational and administrative support to the regulatory affairs department, to obtain and maintain regulatory approvals for Galapagos’ products.


Your role

 

You will assist the regulatory team in the preparation, publishing (including Word and Pdf hyperlinked formats), QC, submission and tracking of submission packages to regulatory authorities.

 

  • With your skills in process improvement and administrative excellence you are creating templates, standard formats and instruction manuals for defined regulatory documents and processes. You ensure the team knows 'where' to find 'what' at any time by adequate archiving, records clean-out activities, managing and organizing the regulatory drive, SharePoint team site, and regulatory library of the Galapagos Document Management System in close collaboration stakeholders
  • To maintain compliance in public transparency databases such as Clinicaltrials.gov and the EU clinical trials register, you will support the development organization in the preparation of adequate records; coordinate and ensure correct data entry
  • You’ll manage the literature ordering process for the regulatory department through RightFindTM or equivalent literature ordering software
  • You’ll assist in the compilation of presentations and regulatory metrics and reporting activities

Requirements

Who are you ?

 

You are an administrative professional with a passion for Life Science or a Life Science professional with a talent for administrative excellence.

 

You have a Bachelor degree and gained 3 or more years work experience in a Clinical Research, Regulatory Affairs or a Medical Department. Experience with electronic submission portals and databases is desirable.

 

Your English is very strong, both in writing and speech. Knowing more languages is an asset. You can demonstrate professionalism in your communications with external and internal contacts.

Your attention to details and eye for quality are well appreciated in the team.  Accuracy is your middle name.

 

You have the skill to understand and follow administrative procedures for a variety of tasks.

 

Your strong organizational skills and your ability to multitask and quickly adapt to changes are essential for success.

 

The Regulatory team  at Galapagos can rely on you.

 

What’s in it for you ?

 

You will be part of a fast growing and amazing company.  As ‘make-it-happener’ you will get all the support you need to make your job successful.  At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.


We are Galapagos : together we can make it happen…!