RA Labelling Coordinator

For 1 of our clients we are urgently looking for an RA Labelling Coordinator who likes to work from home.

  • Do you have at least 2 years of regulatory experience?
  • Do you speak fluent English?
  • Do you have experience with working in a virtual team and/or global organization?

Then you are the ideal candidate for this job, so please apply today to get more information on this job.

Job Description 

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. 

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 
Profile 
  • 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 

Skills

  • Concern for Quality and Order
  • Information seeking
  • Personal Motivation
  • Detail-orientation combined with being able to take a step back (helicopter view)
  • Analytical skills and technical RA knowledge (ability to assess Impact of Label change on current situation)
  • Communication skills and cultural sensitivity in working with stakeholders across countries
  • Proficient in English (incl technical RA English)
  • Team player able to effectively collaborate with colleagues in virtual environment and able to do efficient handovers

Non Technical Skills and Additional Details        

Full time applicants only. We're looking for an individual who is precise, accurate and detail oriented, and able to change priorities as needed. Will be working largely virtually so can work completely remote / from home

Contact Information 

Claire Aerts
+32 15 21 11 04
claire.aerts@valesta.com

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