Senior Specialist, Global Submission Management - Cmc

Bristol Myers Squibb UK

Warsaw, Poland
Base: zł144,100 - zł174,616; bonus/equity: + incen...
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3+ years submissions experience
Ectd publishing tool proficiency
Veeva rim system usage
** Bristol Myers Squibb is seeking a Senior Specialist in Global Submission Management for their Warsaw, Poland location. This role involves managing regulatory submissions for global health authorities, collaborating with stakeholders, and ensuring compliance with regulatory standards. **

Job Summary

  • The role supports end-to-end regulatory activities including the preparation of compliant US IND and marketing maintenance submissions.
  • Employees will collaborate with stakeholders to define eCTD submission strategies and execute the Global Submission Plan.
  • Bristol Myers Squibb offers competitive benefits, services, and programs designed to support work-life balance and career growth.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Senior Specialist in Global Submission Management for their Warsaw, Poland location. This role involves managing regulatory submissions for global health authorities, collaborating with stakeholders, and ensuring compliance with regulatory standards. **

Salary

Base: zł144,100 - zł174,616; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits and programs

Skills & Requirements

Must-have

  • 3+ years submissions experience
  • eCTD publishing tool proficiency
  • Veeva RIM system usage
  • Global regulatory practices knowledge
  • IND and marketing maintenance submissions

Nice-to-have

  • AI and automation tool adoption
  • Stakeholder engagement skills
  • Process improvement initiatives
  • Cross-functional collaboration
  • Presentation skills for diverse audiences

Key Requirements

  • BA/BS degree in science or technology field preferred
  • Minimum 3 years relevant submissions experience
  • Proficiency in English written and oral communication

Work Rights

Not specified

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