Regulatory Affairs Specialist

Roche

Foundational understanding of ectd submission format
Familiarity with documentation assembly and formatting
Knowledge of ms office and adobe acrobat tools
The role involves executing tasks like document formatting, quality checks, tracking, and publishing while learning project planning basics

Job Summary

  • The role involves executing tasks like document formatting, quality checks, tracking, and publishing while learning project planning basics.
  • Candidates must demonstrate a foundational understanding of eCTD submission formats and regulatory requirements including NMPA, ICH, FDA, and EMA guidelines.
  • Roche offers a culture that encourages personal expression, open dialogue, and genuine connections where every voice matters.

Matching Summary

The role involves executing tasks like document formatting, quality checks, tracking, and publishing while learning project planning basics.

Skills & Requirements

Must-have

  • Foundational understanding of eCTD submission format
  • Familiarity with documentation assembly and formatting
  • Knowledge of MS Office and Adobe Acrobat tools

Nice-to-have

  • Proactive motivated learner eager to understand changes
  • Ability to build trustful relationships with stakeholders
  • Exposure to RIM/Veeva Vault systems

Key Requirements

  • Foundational knowledge of eCTD publishing processes
  • Experience with submission software and document management systems

Work Rights

Not specified

Tailored Resume

Cover Letter