Senior Specialist, Global Submission Management - Cmc

Bristol Myers Squibb

Warsaw, Poland
Base: zł144,100 - zł174,616; bonus/equity: + incen...
Hybrid (50% onsite)
Global regulatory submission experience
Ectd publishing tool proficiency
Veeva rim system usage
Bristol Myers Squibb is seeking a Senior Specialist in Global Submission Management to oversee regulatory activities related to IND and marketing submissions. The role demands collaboration across teams to ensure compliance and timely submissions, while offering a supportive and innovative work environment

Job Summary

  • This 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.
  • The company offers a wide variety of competitive benefits, services, and programs to support work-life balance.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Specialist in Global Submission Management to oversee regulatory activities related to IND and marketing submissions. The role demands collaboration across teams to ensure compliance and timely submissions, while offering a supportive and innovative work environment.

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

  • Global regulatory submission experience
  • eCTD publishing tool proficiency
  • Veeva RIM system usage
  • US IND and marketing maintenance submissions
  • Stakeholder collaboration skills

Nice-to-have

  • Critical thinking and problem-solving
  • Artificial intelligence and automation tools
  • Process innovation initiatives
  • Presentation skills for diverse audiences
  • Non-English speaker communication

Key Requirements

  • BA/BS degree in science or technology field preferred
  • Minimum 3+ years relevant submissions experience
  • Foundational knowledge of global regulatory practices

Work Rights

Not specified

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