Job Summary
As a member of the RA Department, the Regulatory Affairs Support Specialist is primarily responsible for assisting the Regulatory Affairs & Vigilance Supervisor and supporting stakeholders in their daily operations.
Job Responsibilities
Product Registration
1. Prepare routine registration files using existing templates
2. Assist in compiling complex registration dossiers
3. Support the distribution and follow-up of change notifications
4. Help draft responses to regulatory authorities
5. Assist in obtaining required documents and certificates
6. Maintain the registration database and track approvals; communicate updates to Business Units and Sales
Labelling & Instructions for Use (IFUs)
7. Coordinate translation and labelling review processes.
8. Ad hoc preparation and maintaining approved label and IFU copies.
9. Support ad hoc review of promotional materials.
Document Control & QMS Support
10. Act as masterfile coordinator in the electronic documentation system; update document properties following organizational changes
11. Support the organization and maintenance of external document records.
General Administrative Support
12. Maintain RA data in regulatory databases
13. Assist with listing requests in the ERP system (SAP)
14. Provide general administrative support: document formatting, literature searches, meeting arrangements
15. Support the Clinical & Vigilance team with ad hoc document preparation
Profile Description
16. Master’s or Bachelor’s degree in Legal Studies, Business Administration, or Sciences, with a strong interest in administrative tasks; or equivalent experience in dossier management, preferably in a regulatory or legal context
17. Proficient in English (written and spoken); additional languages are a plus
18. Comfortable with Microsoft Office, in particular Excel, and open to learning new software tools (SAP)
19. Detail-oriented, well-organized, and a collaborative team player.
Offer
At Terumo, you will contribute to improving healthcare and making a difference in patients’ lives. We provide:
A competitive salary and benefits package
A collaborative, respectful, and inclusive work environment
Opportunities for career growth and professional development
A chance to work with a high-performing, passionate team
During the recruitment process, you will have the opportunity to meet with the hiring manager, and other dedicated Terumo associates.