Regulatory Affairs - Labelling Officer

Location: Leiden, South Holland Salary: competitive
Sector: Life Sciences Type: contract


Job Title: Labelling Coordinator

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

Education and experience
* 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

* 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

Remote work will be almost 100% of the time. If the position matches your experience and interest please send me an email at: j.vanbaalen(@) and apply with your most recent CV + Cover letter. Thanks!