Manager I, Submission Management

Bristor Myers Squibb

Warsaw, Poland
Base: zł162,775 - zł197,245; bonus/equity: + incen...
50% onsite
Ectd submission strategies
Global submission plan execution
Ectd publishing system
Supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant US IND and marketing complex submissions for global health authorities

Job Summary

  • Supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant US IND and marketing complex submissions for global health authorities.
  • Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
  • Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.

Matching Summary

Supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant US IND and marketing complex submissions for global health authorities.

Salary

Base: zł162,775 - zł197,245; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Not specified

Skills & Requirements

Must-have

  • eCTD submission strategies
  • Global Submission Plan execution
  • eCTD publishing system
  • RIM systems (Veeva RIM)
  • regulatory practices and guidelines

Nice-to-have

  • artificial intelligence and automation tools
  • collaboration with non-English speakers
  • driving innovation and process simplification

Key Requirements

  • BA/BS degree, science / technology field preferred
  • 3+ years relevant submissions experience
  • Strong analytical and critical thinking skills
  • Effective communication skills in English
  • Solid project management abilities
  • Builds collaborative relationships

Work Rights

Not specified

Tailored Resume

Cover Letter