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
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