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  • Location

    Leiden, Netherlands

  • Job title:

    Compliance Specialist Narcotics

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    43357

Compliance Specialist Narcotics

The Company

For a well-known pharmaceutical company, specialised in inhalation anesthetics, I am looking for a compliance specialist for managing submissions of Narcotics. The company has opened a new office in the Netherlands due to the Brexit.

Role Description
The European controlled Substances Coordinator is responsible for the maintenance, submission and controlled substances filling of narcotic applications and licences. You will be repsonsible for the safeguard of the whole supply chain regarding to narcotics

Responsibilities
  • Apply for the required import/export licences for narcotics in 70 different countries
  • Liaise with regulatory authoroties for Controlled substances
  • Review and audit Batch Records, Supply and Packaging documents
  • Auditing of 3PLs and transport companies
  • Assist in sales in determining licecenses for new distributors/countries
  • Conduct training sessions for employees who are responsible for handling narcotics
  • Coordinate with the Serialization team for internal/external sites in case of failed EPCIS
  • Track and maintain a controlled narcotics inventory for compliance reporting

Requirements

  • BSc. in Pharmacy or (Bio-)Engineering
  • 2 years of experience in pharmaceutical/biologics manufacturing or distribution
  • Experience with narcotics is a must have
  • Strong knowledge of GMP/GDP 
  • Fluent in English, other European languages are a plus

Other information
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