Global eCTD Submissions Lead (Senior)

Michael Page; Lisboa; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Global pharmaceutical organization

Collaborative multicultural work env

Job summary

Michael Page is seeking a Senior Regulatory Operations Specialist - Electronic Submissions to manage global eCTD submissions, ensure quality and timeliness, and guide cross-functional teams. The role requires strong experience in regulatory publishing and familiarity with Lorenz docuBridge and Veeva Vault.

You will collaborate with Regulatory Affairs and other departments, handle multiple projects, and mentor junior staff while maintaining up-to-date knowledge of evolving global submission

Qualifications

• Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related discipline.
• Minimum of 5 years in Regulatory Operations, Electronic Submissions, or Regulatory Publishing in pharma.
• Strong experience with eCTD publishing and submission processes.
• Experience with Lorenz docuBridge; familiarity with Veeva Vault and Documentum D2.
• Understanding of global regulatory submission requirements and dossier formats.

Responsibilities

• Publish and manage regulatory submissions in eCTD and non-eCTD formats for global markets.
• Perform technical quality control and validation of electronic submissions for compliance.
• Coordinate submission schedules and ensure timely delivery against milestones.
• Serve as SME for publishing activities and guide regulatory stakeholders.
• Troubleshoot publishing and validation issues for successful submissions.
• Support electronic transmission and archival of regulatory dossiers.
• Contribute to process improvements and system enhancements.
• Keep knowledge up-to-date on evolving eCTD requirements and technologies.
• Support regulatory projects and system implementation initiatives.
• Mentor junior colleagues and share knowledge within Regulatory Operations.

Skills

Regulatory Ops

Electronic Submissions

Cross-functional collaboration

Project management

Education

Life Sciences/related degree

Tools

Lorenz docuBridge

Veeva Vault

Documentum D2

Job description

Michael Page is seeking a Senior Regulatory Operations Specialist - Electronic Submissions to manage global eCTD submissions, ensure quality and timeliness, and guide cross-functional teams. The role requires strong experience in regulatory publishing and familiarity with Lorenz docuBridge and Veeva Vault.

You will collaborate with Regulatory Affairs and other departments, handle multiple projects, and mentor junior staff while maintaining up-to-date knowledge of evolving global submission