Regulatory Submission Officer
Roche
full-time
Posted on:
Location Type: Office
Location: Beijing • 🇨🇳 China
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Execute eCTD submission activities in line with submission/content strategy and compliance with regulations
- Support full adoption of eCTD submissions
- Contribute to eCTD capability building
- Provide eCTD training and support knowledge management
- Stay updated on regulatory changes
- Contribute to vendor oversight
- Support development of strategic plans for eCTD submissions
- Support group leader on exploring new ways of working
Requirements
- B.S. or above in Pharmacy, Medical, Biology or related field
- > 3 years’ experience in Pharma MNCs, including at least 2 years in regulatory submissions
- Experience in delivering eCTD submissions is required
- Independent working
- Experiences in crisis management
- Chinese (mother-tone level) and English (proficiency level)
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
eCTD submissionsregulatory submissionsknowledge managementcrisis management
Soft skills
independent working