Derks Vacature Regulatory Affairs

Manager Affiliate Operations

  • Freelance
  • Interim
  • Leiden
  • Referentienummer: MSP/ 24-073 - DD


  • a quality orientated organisation in the pharmaceutical industry
  • a temporary contract or an independent contract from Derks & Derks Secondment & Interim
  • a contract for 8 months with the possibility to extend



As Manager Affiliate Operations you will be the first point of contact for questions from PV Affiliate staff and other RA, PV, and MA departments. You collaborate with third parties such as vendors and business partners, and you are responsible for guiding DSOs to ensure compliance of local PV systems, processes and procedures with global/regional regulatory requirements and internal policies. Think about ICSR handling, CAPAs, root cause analysis and training requirements. By doing so you make sure that there is a readiness for audit and inspection activities which have to be prepared beforehand, guided during and evaluated afterwards. You will be working on site on Tuesday and Thursday, and from home on the other days. Traveling time is estimated at 50% since you will also have to go to other locations.



  • BS/MSc in Health Science, Life Science or Medical Science
  • 5+ years’ experience within PV, as DSO or equivalent
  • in-depth understanding of all aspects of PV, compliance mentality, documentation, and IT systems
  • culturally sensitive, tactful, influencing, problem-solving and proactive
  • good communication skills in English



The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the Middle East and Africa. They operate on a global level and most teams have a global focus. They have everything in house like research, development, manufacturing, warehousing, but also sales and marketing. It is their hope to change tomorrow and to improve the lives of individuals by providing innovative medicines in areas of health where there is an urgent need for better treatments. The organisation is clearly focused on bringing high-quality medicines to the market to reach their goals. At this moment they are open to meet an enthusiastic candidate for a temporary position as Manager Affiliate Operations at their site in Leiden.



Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/24-073, to Björn Baarveld For further information, please call, text or Whatsapp Björn via +31 (0)6 51 98 16 13.


Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.


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Tagged as: Life Sciences

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