Technical Changes Labeling Specialist (Global Regulatory Affairs)

at  Sanofi US

Budapest, Közép-Magyarország, Hungary -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate07 Sep, 2024Not Specified08 Jun, 20242 year(s) or aboveChange Management,Excel,Interpersonal Skills,Outlook,Powerpoint,Working Experience,Change Control,Cultural AwarenessNoNo
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Description:

Job title: Technical Changes Labeling Specialist
Location: Budapest, Hungary
Flexible working: 60% home, 40% office
Job type: Permanent, full-time

Responsibilities:

  • Perform regulatory evaluations within existing Sanofi Quality Management Systems / Change Control systems
  • Coordinate and liaise with key stakeholders to define regulatory submission strategies- exchange data and information, monitor progress, take action, record action to coordinate and make progress with change processing
  • Compile regulatory documents to support corporate publishing and dispatch submission processes
  • Prepare global communications and information packages for local distribution
  • Maintain regulatory requirements database in collaboration with Country Regulatory Heads
  • Participate to the preparation / update of quality document, processes, tool enhancement and training materials
  • Closely interact with colleagues in quality, performance, and business process/operational excellence roles to ensure optimal processes and tools are developed and implemente

REQUIREMENT SUMMARY

Min:2.0Max:3.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Budapest, Hungary