Senior Manager, Submission Management Clinical Trials

Bristol Myers Squibb

**
7+ years regulatory submissions experience
Global cta dossier preparation
Eu ctis substantial modifications management
** Bristol Myers Squibb is seeking a Senior Manager for Submission Management in Clinical Trials to oversee regulatory activities and ensure compliance for clinical trial submissions. The role requires extensive experience in regulatory submissions, collaboration with global stakeholders, and team leadership within a supportive and innovative company culture. **

Job Summary

  • This role supports end-to-end regulatory activities for assigned projects, including leading the preparation of compliant clinical trial submissions.
  • The position requires managing data for EU CTIS and substantial modifications while monitoring the regulatory assessment process with health authorities.
  • Bristol Myers Squibb offers a wide variety of competitive benefits and programs to support employees in pursuing their goals both at work and personally.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Senior Manager for Submission Management in Clinical Trials to oversee regulatory activities and ensure compliance for clinical trial submissions. The role requires extensive experience in regulatory submissions, collaboration with global stakeholders, and team leadership within a supportive and innovative company culture. **

Skills & Requirements

Must-have

  • 7+ years regulatory submissions experience
  • Global CTA dossier preparation
  • EU CTIS substantial modifications management

Nice-to-have

  • Team leadership and mentoring capabilities
  • Continuous improvement initiative drive
  • Stakeholder negotiation skills

Key Requirements

  • BA/BS degree in science or technology field preferred
  • 7+ years relevant regulatory submissions experience
  • Ability to lead a team of direct reports

Work Rights

Not specified

Tailored Resume

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