vacature regulatory-affairs

RA Associate CMC

  • Tijdelijk dienstverband
  • Leiden
  • Referentienummer: DT/19-172-DD

Derks & Derks Detachering

A regulatory position in CMC for at least 6 months, for a pharmaceutical company.

Offer
  • a position where your experience is recognized
  • working in international projects
  • a contract for at least 6 months
  • changes to growth is your knowledge
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. They have several locations in The Netherlands and are willing to hire a new team member for the facility in Drenthe or Zuid-Holland. They would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented RA Associate CMC.

Position

As a RA Associate CMC you will be responsible for the preparation of variation packages, renewals, new MAA (non-ICH) and response documents. All concerns both EU and non-EU (i.e. EMEA region) submissions and both CTD module 3 (and QOS) and Normative Document for small molecules. You will prepare the baseline submissions and contribute to the assessment / comparison of updated ICH/non-ICH file as part of a global compliance project. You will create overviews of available quality modules in order to prepare for migration to another document management system. You will also contribute to the compliance check of CMC-RA information in the applicable systems. In this role you will work in a small team and report to the manager of the team.

Profile
  • bachelor or Master degree
  • at least 3 years of experience in CMC-RA
  • experience in variation packages, renewals, new MAA (non-ICH) and response documents
  • preferably experience with Normative document preparations
  • IT wise in Trackwise, and MS. Office
  • good communication skills
  • full command of written and verbal business English
Response

Interested? Please send your resume and motivational letter by email, with reference number DT/19-172-DD to Office@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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