Regulatory affairs IT officer
For an international manufacturer of medicine with over 140 years of experience, we are seeking a regulatory IT officer. If you are ready for a new challenge in which you can expand you experience and contribute to the success of this international orientated organisation, do not hesitate to get in contact.
We're hiring a regulatory affairs IT officer
How your potential will be optimised
As an IT RA officer you will work in a challenging and fast changing environment. You will assist the director regulatory affairs and the BU regulatory affairs manager in creating and maintaining relevant IT tools to support the RA department with product approvals.
- Determine with the RA Director and relevant RA managers all IT tools which are required within the RA departments (e.g. e-CTD, eDMS, trackwise, IDMP)
- Lead the IT tool development projects from an RA point of view in full cooperation with the relevant project managers of the IT department. Help to translate RA requirements into IT systems.
- Lead the roll out of these projects
- Prepare all relevant procedures for these RA IT systems.
- Perform trainings of relevant RA employees
- Maintain all existing IT RA tools in order to comply to the latest regulatory requirements.
- Keep track of the IT road maps and coordinate the required validation in case of updates or changes.
- Assist RA managers/officers in inclusion of necessary documents/ data in these systems
- Give user rights to relevant RA employees in cooperation with RA Director and Managers
- Track all new regulations/guidance in the field of IT for RA purposes to make sure timely implementation of new/updated IT systems
- Built up a good network with relevant software vendors
A track-record to fit in perfectly
- University degree in pharmacy, chemistry or IT science
- At least 2 years of experience with the development and management of IT tools in the pharmaceutical industry
- Fluent in English both written and oral
- Good eye for detail, be convincing and be able to translate RA requirements into IT requirements
What you will get for your efforts
- Market conform salary
- 40 hour work week
- 25 days holiday
- 13th month
- permanent contract
- training bonus
- career growth opportunities
Where the magic happens
You will work at a market leader in the health care industry that strives for excellence. This international organisation offers a vibrant work environment with great opportunities for personal and professional development. You will work together with professional and ambitious colleagues within an international work environment.
Apply now online for the role of regulatory affairs officer or send your CV to Gaia Brouwers. If you would like further information about this project or similar projects, call Gaia Brouwers on 020-530 5888.
Progressive Recruitment is gespecialiseerd in de bemiddeling van professionals binnen de sectoren IT, Global Energy & Natural Recources, Life Sciences, Supply Chain en Engineering. Wij kunnen je helpen bij je zoektocht naar een tijdelijke opdracht, maar ook als je zoekt naar een permanente functie in deze sectoren. Kijk voor meer informatie op www.progressiverecruitment.com of www.progressivege.com
Progressive Recruitment is specialized in recruiting professionals in the sectors IT, Global Energy & Natural Recources, Life Sciences, Supply Chain and Engineering. We can help you find temporary and permanent job opportunities in these industries. For more information, visit www.progressiverecruitment.com or www.progressivege.com.