Senior Global Submission Manager

Overview

The Position Make an impact on global regulatory excellence – and help shape digitally enabled submission operations. As a Senior Global Submission Manager, you will play a pivotal role in driving highquality regulatory submissions worldwide. By connecting scientific expertise with digital capabilities, you help ensure streamlined processes, data integrity, and globally aligned submission strategies. In this dynamic environment, you will collaborate with experts across Regulatory Affairs and adjacent functions to strengthen both operational execution and continuous improvement. Join us to enhance submission quality through structured content, rigorous metadata governance, and innovative workflow optimization. Your contributions will directly support faster, more efficient pathways to bring therapies to patients.

This position can be filled in Ingelheim or Biberach. This position has a hybrid setup with minimum 1 day per week on site. This position is limited for 2 years. This position is part time eligible with 80%.

Responsibilities

• In your new role, you will ensure the planning, coordination, and delivery of global regulatory submissions e.g. CTA/IND, NDA/BLA, MAA with scientific rigor and operational precision.
• You will develop and maintain Global Submission Content Plans while promoting transparency and alignment across all involved functions.
• Additionally, you’ll drive crossregional collaboration to achieve timely, compliant, and highquality submissions.
• With your expertise, you will apply global regulatory standards and leverage digital tools such as RIM systems and eCTD platforms to strengthen planning, tracking, and compilation workflows.
• By shaping and improving global submission processes, SOPs, and governance structures, you will advance process harmonization.
• Furthermore, you will identify automation opportunities and support metadata-driven workflow enhancements that reduce manual work and increase data integrity.
• You will conduct rootcause analyses and contribute to continuous improvement initiatives using methods such as Lean or Kaizen.
• Lastly, you will support global project management activities, including milestone tracking, risk management, and effective stakeholder communication.

Requirements

• Completed university degree in Life Sciences, Pharmacy, Medical Informatics, Regulatory Affairs, Biomedical Engineering, or a related discipline
• Several years of experience in regulatory submissions, digital regulatory operations, RIM processes, document lifecycle management, or project management in a GxP-regulated 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 e.g. VeevaVault, ArisGlobal or Ennov
• Experience with eCTD publishing tools and familiarity with structured content management or metadata-driven processes
• Proficiency with reporting and analytics tools e.g. PowerBI, Tableau and project management applications such as MSProject, Jira or Smartsheet
• Strong analytical skills, a structured working approach, and the ability to convert process gaps into actionable improvement initiatives
• Excellent collaboration skills and the ability to operate effectively in international, cross-functional teams

Contact

Ready to contact us? If you have any questions about the job posting or process — please contact our HR Direct Team, Tel: +49 (0) or via mail:

Recruitment process

Online application - The job posting is presumably online until March 26th, 2026. We reserve the right to take the posting offline beforehand.

Why Boehringer Ingelheim?

Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations. Want to learn more? Visit