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  • Location

    Regio Leiden, Netherlands

  • Job title:

    Compliance Specialist Narcotics

  • Sector:


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Onze klant is een organisatie in de farmaceutische industrie gelegen in de provincie Zuid-Holland.

Do you have?
Bachelor degree in Supply Chain Management
Do you have? Knowledge of GMP and GDP
Do you have? Experience or affinitiy with a pharmaceutical, biologics manufacturing or distribution environment
Do you speak? Good English and Dutch (written and spoken)


The company

Our client is one of the largest producer of inhaled anesthetics and a global player in hospital generics.


Role description

In this coordinating role you're main responsibility will be validating and managing import and export licenses of narcotics in order to make sure of a uninterrupted supply chain for the European market.



  • Manage the submission, maintenance, and controlled substance filings for all EU PCC applications, licenses, and registrations. You will update and remove drug codes and or drug schedules from licenses
  • Apply for all required import/export narcotics licenses in the EU and elsewhere
  • Maintain quotas of controlled substances and proper accountability of controlled substances
  • Prepare all required submissions and reports to appropriate regulatory agencies in a timely manner
  • Develop, monitor and enforce procedures to prevent material diversion ensure that all activities are controlled through approved procedures
  • Host regulatory controlled audits (twice a year)
  • Review and audit batch records, packaging and supply documents
  • Assist Sales in determining licenses required for new distributors and countries
  • Track and maintain a controlled substances inventory for compliance reporting
  • Track and complete all reporting requirements from all appropriate EU regulatory bodies
  • Insure that business processes and conduct of PCC regarding production, storage, handling, sales and distribution of narcotics are compliant with the local and international regulations
  • Coordinate and manage the updates of the narcotic site license(s) addressed to the local health authorities regarding production, sales & distribution of narcotics
  • Implement CAPAs and remediation plans on deviations as required
  • Assure a good cooperation between the narcotic department and the health authorities
  • Work close with QA and logistics ensure all shipment data is reported successful


  • Bachelor or Master degree in Supply Chain Management or equivalent
  • Experience in a pharmaceutical, biologics manufacturing or distribution environment is an advantage
  • Knowledge of GMP and GDP
  • Good in English and Dutch (written and spoken).
  • Computer skills: MS Office, Excel, PDF
  • Knowledge on the GS1 standards e.g. GTIN, NTIN, GLN, SGTIN

For more information you can contact Rutger Koning at / +31 85 444 650