Regulatory Data RIMS Specialist

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Hørsholm

Are you passionate about data extraction and reports? Do you want to join a team of great and highly skilled colleagues? And do you furthermore have experience working with Regulatory Information Management (RIM) Systems or similar databases within the life science industry? If so, the Compliance and Operations team at ALK Global Regulatory Affairs really wants to hear from you!

The position
You will be part of the Global Regulatory Affairs (GRA) department that counts approximately 60 people, located at our headquarters in the DTU Science Park in Hørsholm.

Joining the Compliance and Operations team you will be working closely with 8 great team members and in the role as Regulatory Data RIMS Specialist you will be given considerable opportunities to develop within a range of responsibilities, primarily as a regulatory data expert.

Fields of responsibility

  • Setting up and delivering Veeva Vault RIM Reports and dashboards to stakeholders and management.
  • As a business administrator, perform data configuration and quality control within our Veeva Regulatory Information Management System (RIMS).
  • EMA IDMP intelligence and project support.
  • EMA xEVMPD database QC and product data submission within Veeva Vault RIM.
  • Support to the authoring and reviewing process of QMS documents.
  • Support our Veeva Vault RIM system-controlled update release process.
  • Provide training and support to team and department in areas of expertise.


Your profile
You have experience working with IT systems and databases in a GxP environment, preferably with RIM systems in the life science industry. You possess strong Microsoft Excel and data structuring skills. You are experienced in delivering accurate data reports in a comprehensible and timely manner and capable of structuring and orienting yourself in large data sets.

Your qualifications

  • Experience working with Veeva Vault RIM or similar Regulatory Information Management Systems is an advantage, but not a requirement.
  • High proficiency in Microsoft Excel with skills in data analysis, formula creation and spreadsheet management.
  • Experience working in Regulatory Affairs within the life science industry is a plus.
  • Strong analytical skills and a structured work approach.
  • Fluency in English or Danish.
  • A good sense of humor and the wish to be part of a successful and hardworking team.


Why Join Our Team and ALK


  • An inclusive and empowering work culture that values individual growth.
  • Opportunities for advancement and career progression.
  • Access to training programs and resources to enhance your professional development.
  • Room for experimentation and the freedom to introduce innovative ideas.

If you are seeking a role where you can freely develop yourself while being part of a collaborative and supportive team, we encourage you to apply.

The Compliance and Operations team in GRA is on an exciting trajectory as Regulatory data is playing an increasingly important role in the life science industry. By joining ALK you will get the opportunity to be part of our exciting journey where you will be able to create results, develop yourself, solutions and ALK together with highly skilled and engaged colleagues in an international environment while helping millions of people suffering with allergy.

Visit us at www.alk.net to learn more about our company. If you have questions about the position, you are welcome to contact Manager, Jesper Kærgaard Kristensen on telephone +45 41 95 90 72.

We are looking forward to hearing from you!


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Hørsholm.

Jobbet er oprettet på vores service den 7.12.2023, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Hørsholm
  • Mandag den 01. juli 2024

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