Submission Manager

Job Summary

The Regulatory Submission Manager at Roche is responsible for delivering high-quality regulatory submissions to Health Authorities worldwide. This role involves editing complex technical documents, managing the flow of information, and ensuring data accuracy and quality.

Key Responsibilities

• Edit complex technical documents for clarity, grammar, spelling, and punctuation, ensuring adherence to applicable regulatory guidelines.
• Manage the flow of information and input of data into the regulatory information management system, maintaining data quality and accuracy.
• Support and provide coordination, compilation, and submission management in the preparation of new and existing regulatory applications, in compliance with health authority regulations.
• Collaborate with internal partners, including Regulatory Publishing, Project Management, and Business Systems, to ensure seamless submission processes.
• Facilitate knowledge sharing and best practice workshops, contributing to continuous improvement and process optimization.

Requirements

• Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or related field.
• Proficiency in RIM - Regulatory Information Management system - preferred but not mandatory.
• Strong track record as an editor, including at least three years of professional experience, in a scientific or technical field.
• Previous experience with regulatory documents in CTD structure and other ICH, FDA, and EMA guidelines, and global submission dossiers or in the biotech or pharmaceutical industry is beneficial.
• Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat, and experience with document management systems and document sharing systems.

Competencies and Skills

• Strong written and verbal communication skills.
• Ability to interface effectively with a wide range of stakeholders, including PTR submission leads, scientific subject-matter experts, reviewers at all levels, and colleagues located in other countries.
• Strong organizational and time management skills, with the ability to deliver under pressure and work flexibly to support changing assignments and priorities.