Senior Specialist, Submission Management

Bristol Myers Squibb UK

Warsaw, Poland
Base: zł116,650 - zł141,347; bonus/equity: + incen...
Hybrid (50% onsite)
Global regulatory submission experience
Eu ctis and cta dossier preparation
Veeva rim system proficiency
Bristol Myers Squibb is seeking a Senior Specialist in Submission Management to support regulatory activities for clinical trials in Warsaw, Poland. The role involves preparing and managing submissions for global health authorities, ensuring compliance with regulatory standards while offering a collaborative work environment and opportunities for professional growth

Job Summary

  • This role supports end-to-end regulatory activities for clinical trials, ensuring compliance with global health authorities.
  • The position involves preparing and distributing global Clinical Trial Application dossiers while managing data for EU CTIS submissions.
  • Employees can work remotely up to 50% of the time over a two-week period with flexible scheduling options.

Matching Summary

Match Score: 75

Bristol Myers Squibb is seeking a Senior Specialist in Submission Management to support regulatory activities for clinical trials in Warsaw, Poland. The role involves preparing and managing submissions for global health authorities, ensuring compliance with regulatory standards while offering a collaborative work environment and opportunities for professional growth.

Salary

Base: zł116,650 - zł141,347; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Competitive benefits, services, and programs provided

Skills & Requirements

Must-have

  • Global regulatory submission experience
  • EU CTIS and CTA dossier preparation
  • Veeva RIM system proficiency

Nice-to-have

  • Stakeholder engagement skills
  • AI and automation tool adoption
  • Process improvement initiatives

Key Requirements

  • BA/BS degree in science or technology field
  • 1+ years relevant regulatory submission experience
  • Proficiency in English written and oral communication

Work Rights

Not specified

Tailored Resume

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