The role requires solid knowledge of regulatory agency requirements for electronic submissions format and delivery including profuse knowledge of eCTD specifications
Job Summary
The role requires solid knowledge of regulatory agency requirements for electronic submissions format and delivery including profuse knowledge of eCTD specifications.
Candidates must have practical hands-on experiences in executing eCTD applications involving the assembly, formatting, publishing and submissions of regulatory dossiers with HAs.
Roche encourages personal expression, open dialogue, and genuine connections where every voice matters to prevent, stop and cure diseases.
Matching Summary
The role requires solid knowledge of regulatory agency requirements for electronic submissions format and delivery including profuse knowledge of eCTD specifications.
Skills & Requirements
Must-have
Solid knowledge of regulatory agency requirements
Hands-on experience executing eCTD applications
Proficiency with MS Office and Adobe Acrobat
Experience delivering eCTD submissions to HAs
Minimum 3 years in Pharma MNCs
At least 2 years in regulatory submissions
Nice-to-have
Experience working with RIM/Veeva Vault systems
Ability to identify opportunities for process improvement
Strong interpersonal and communication skills
Crisis management experience
Digital mindset and information management skills
Key Requirements
B.S. or above in Pharmacy, Medical, Biology or related field
> 3 years' experience in Pharma MNCs
At least 2 years in regulatory submissions
Chinese mother-tongue level and English proficiency