Senior Manager, Regulatory Submissions – Hybrid

Bristol Myers Squibb

Warszawa

Hybrid

PLN 251,000 - 304,000

Full time

14 days+

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Benefits offered by this job

Remote-friendly flexibility
Global team exposure
Competitive benefits

Job summary

Bristol Myers Squibb is seeking a Senior Manager - Submission Management in Warsaw, Poland to lead end-to-end regulatory submissions for assigned projects. You will coordinate IND and marketing submissions for global health authorities and drive continuous improvement initiatives.

Join a global development team with leadership responsibilities, mentoring staff and managing resources while ensuring adherence to regulatory standards and timelines.

Qualifications

  • BA/BS degree required; science/technology field preferred.
  • 7+ years of relevant submissions experience and people management experience.
  • Proficient knowledge of global regulatory practices and submission requirements.
  • Excellent written and spoken English; ability to simplify complex topics for stakeholders.

Responsibilities

  • Define IND and marketing submission strategies and document requirements.
  • Prepare and deliver eCTD submission dossiers for global markets.
  • Drive Global Submission Plan execution with cross-functional teams.
  • Lead submission production activities and lifecycle management submissions.
  • Communicate regulatory changes to the business and support continuous improvement.

Skills

Regulatory submissions
Team leadership
English communication
Project management
Cross-functional collaboration

Education

BA/BS degree
Science/technology field preferred

Job description

Bristol Myers Squibb is seeking a Senior Manager - Submission Management in Warsaw, Poland to lead end-to-end regulatory submissions for assigned projects. You will coordinate IND and marketing submissions for global health authorities and drive continuous improvement initiatives.

Join a global development team with leadership responsibilities, mentoring staff and managing resources while ensuring adherence to regulatory standards and timelines.

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