For one of our clients, a well-known pharmaceutical company, we are urgently looking for an experienced Regulatory affairs professional (CMC variations and labeling changes).
The company is located in Leiden, flexibility towards homebased working is offered.
Flexibility in terms of working hours is required, since you will have contacts working in different time zones.
Interested? Don’t hesitate, and apply as soon as you can!
The Regulatory Management Center (RMC) is a new regional organization to handle the majority of LOC (Local Operating Company) activities led by senior regional regulatory staff, where they will handle tactical LCM processes (CMC Variations and Labeling Changes) in the region. The Center will be embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOCs and regional and global departments.
The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organization).
The responsibility of RMC Professionals is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers, manage Agency questions when required and ensure post-approval activities to take place for those submissions.
- Lead and facilitate LOC CMC variation / label change processes from global dispatch to kick-off of local implementation following RMC processes
- Prepare submission plan based on global dispatch and country specifics
- Prepare submission-ready dossier based on local regulations and country specific requirements covered in “recipe book” – in collaboration with LOC staff
- Assess and implement label changes
- Involve specialists for specific process steps, eg. for ePackmat
- A minimum of a University degree or equivalent by experience
- 5+ years of submission handling experience
- Experience of working in a virtual team and/or global organization would be an asset .
- Previous experience in RA role as Associate, Professional or similar role is of advantage.
- In depth knowledge of local and regional regulations/legislation.
- Experience in working with limited supervision and able to make independent decisions
- Excellent verbal and written communication skills – proficiency in written and oral English
- Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
- Proactive team player, able to take charge and follow-through.
- Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
- Proficient use of technology including RA tracking systems (TrackWise / SPS/MPD) - preferred
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