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GSK·7 days ago
7 days ago

Regulatory Manager, Delivery – CMC RA

Poznan Grunwaldzka, PolandFull-timeMid · 5-10 years

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About this role

Become part of our team as a Regulatory Manager, leading and coordinating CMC regulatory activities to support timely submissions and lifecycle management for our Vaccines portfolio. Oversee complex submissions, manage multiple projects, and collaborate with cross-functional teams. Ideal for experienced professionals in regulatory affairs within the pharmaceutical or biotech sector.

Skills

  • cmc regulatory affairs
  • ctd module 3
  • post-approval changes management
  • regulatory submissions
  • project coordination
  • quality management systems
  • gmp interfaces
  • regulatory strategies
  • communication
  • problem solving
  • strategic leadership
  • pharmaceutical regulatory compliance
  • digital fluency
  • learning agility
  • influencing without authority
  • change control
  • regulatory document management systems
  • regulatory process improvement
  • stakeholder management
  • cross-functional collaboration
  • regulatory strategy
  • regulatory compliance
  • regulatory strategy development
  • regulatory negotiation
  • health authority communication
  • mentoring
  • best practice sharing
  • digital transformation
H1B sponsor likely
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