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Regulatory Affairs Junior

  • Type Contract
  • Salary Negotiable
  • Location Netherlands, Netherlands
  • Sectors Pharma & Biotech

LABELLING COORDINATOR

Location: Leiden - can work completely remote
Hours per week: 40

RA Labelling Coordinator with cross-regional scope of work.
Support LOCs in submitting compliant local labels in time by quality check of labelling documents in EMEA and Asia Pacific.

MAIN DUTIES AND RESPONSIBILITIES
* Maintain oversight of compliant labels for EMEA.
* Ensure updates are integrated into the latest available local label in a compliant manner
* Archive/store the local label in English and local language in a central repository
* Initiate content deviation process, if required
* Ensure updates are integrated into artwork in a compliant manner

EXPERIENCE AND EDUCATION
* 5 or more years of regulatory experience, labelling experience preferred
* University degree or equivalent by experience
* Previous experience in RA role as Associate, Professional or similar role is of advantage
* Able to influence without authority - experience in a matrix structure
* Able to make independent decisions
* Experience of working in a virtual team and/or global organization
* Multitasking, accurate and conscientious
* Knowledge of regulatory IT systems (especially document management and planning)
* Language capabilities: fluent in English, generic feel for languages

APPLY NOW
Are you the new Labelling Coordinator? Apply now online or to speak to Michelle Smit via 020 522 15 88 or m.smit[a]realstaffing.com