Regulatory Affairs data officer

You will coordinate verification activities in a Marketing Authorisation data tracking system

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Wat ga je doen

As a Regulatory Affairs data officer you will be responsible for the coordination of data verification activities in a Marketing Authorisation data tracking system (InSight).

  • Coordinate verification of CMC baseline data and MA baseline data in InSight across EMEA Regulatory Affairs teams (Local Operating Companies LOCs and Therapeutic Areas TAs), under the oversight the EMEA RIM InSight Implementation Lead and in close collaboration with the EMEA InSight Data Entry Specialists
  • Liaise with the global RIM InSight team and CMC RA team on the data verification process, roles and responsibilities, to ensure alignment between global and EMEA expectations
  • Provide GRA EMEA LOCs and TAs with training, guidance and communication on the required verification activities
  • Support LOCs in verification activities as needed, including performing actual verification where appropriate and possible
  • Liaise with CMC RA to ensure EMEA verification feedback on CMC data is assessed and actioned
  • Liaise with EMEA Data Entry Specialists to ensure EMEA verification output is accurately entered/reflected in InSight.

Wat vragen wij

For the position of a Regulatory Affairs data officer  we are looking for an experienced candidate in Regulatory Affairs and experience in CTD Module 3 data

  • Understanding of local registration data tracking requirements
  • Knowledge of compliance requirements and advanced process thinking
  • Proven ability to deliver complex projects on time
  • Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level
  • Excellent cross-cultural communication skills in English
  • Flexibility and proactivity

Wat hebben we te bieden

  • Fulltime position (40 hours/week) is strongly preferred, However, 32 hours/week may be discussable for the ideal candidate
  • Secondment via CheckMark Labrecruitment
  • The position is at Leiden office or home-based with 1 trip to Leiden per week/2x per month. Furthermkore you must be flexible for incidental travel (10%).

Waar ga je aan de slag

A global biotech company that focuses on the development, pro­duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

Wil je meer weten?

Esther Moerdijk
0182 590 215
Na Rae de Jong
0182 590 216
Vacaturenummer: 6191

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