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BOBoehringer Ingelheim

Senior Global Submission Manager(m/w/x)

Ingelheim am Rhein, Biberach
Part-timeWith Home OfficeSenior
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Global regulatory submissions (CTA/IND, NDA/BLA, MAA) planning, coordination, and content plan development at a global pharmaceutical company. Hands-on experience with RIM platforms (VeevaVault, Aris Global, Ennov) essential. Hybrid work setup.

Requirements

  • University degree in Life Sciences, Pharmacy, Medical Informatics, Regulatory Affairs, Biomedical Engineering, or related discipline
  • Several years experience in regulatory submissions, digital regulatory operations, RIM processes, document lifecycle management, or project management in GxP environment
  • Sound understanding of CTD/eCTD requirements, global regulatory guidelines, and document management standards
  • Strong affinity for digital systems and hands-on experience with RIM platforms (VeevaVault, Aris Global, Ennov)
  • Experience with eCTD publishing tools and familiarity with structured content management or metadata-driven processes
  • Proficiency with reporting/analytics tools (PowerBI, Tableau) and project management applications (MSProject, Jira, Smartsheet)
  • Strong analytical skills, structured working approach, and ability to convert process gaps into improvement initiatives
  • Excellent collaboration skills and ability to operate effectively in international, cross-functional teams

Tasks

  • Plan global regulatory submissions (CTA/IND, NDA/BLA, MAA)
  • Coordinate global regulatory submissions (CTA/IND, NDA/BLA, MAA)
  • Deliver global regulatory submissions (CTA/IND, NDA/BLA, MAA)
  • Develop Global Submission Content Plans
  • Maintain Global Submission Content Plans
  • Promote transparency and alignment across functions
  • Drive cross-regional collaboration
  • Apply global regulatory standards
  • Leverage digital tools (e.g., RIM, eCTD platforms)
  • Shape global submission processes, SOPs, and governance
  • Improve global submission processes, SOPs, and governance
  • Identify automation opportunities
  • Support metadata-driven workflow enhancements for efficiency, data integrity
  • Conduct root-cause analyses
  • Contribute to continuous improvement initiatives (Lean, Kaizen)
  • Support global project management activities
  • Track project milestones
  • Manage project risks
  • Communicate effectively with stakeholders

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • VeevaVault
  • Aris Global
  • Ennov
  • eCTD publishing tools
  • PowerBI
  • Tableau
  • MSProject
  • Jira
  • Smartsheet

Benefits

Flexible Working

  • Hybrid work setup
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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