Regulatory Affairs Executive

IF YOU WOULD LIKE TO APPLY FOR THIS JOB, PLEASE COPY AND PASTE THE FOLLOWING URL INTO YOUR BROWSER:
<https://www.roche.com/careers/jobs/jobsearch/job.htm?id=E-201909-125833&locale=en&title=Regulatory+Affairs+Executive>
THE DIRECT APPLICATIONS VIA THAT LINK WILL BE PRIORITIZED.

· Plan & execute new registration projects as assigned by RA manager. Effectively manage multiple project schedules & priorities.
· Prepare registration dossiers according to regulatory requirements and relevant government regulations for new launched and existing in-vitro diagnostic products
· Follow products update and submit change/ amendment dossier for registered products
· Register products’ promotional material/symposium for marketing activities
· Ensure products’ license are compliant with regulatory requirements with the necessary supporting document
· Ensure re-dressing, sub-labeling, storage and packaging requirements are compliant with Global recommendation
· Ensure the translation of all product inserts for uploading to Global e-library and for local distribution as request from business
· Organization of certificates (free sales cert and etc.) and registration product dossier
· Provide administrative support to the RA team such as organizing and maintaining RA documentation in Registration Database
· Coordinate with local BUs to prepare document that fulfill importing countries' requirement
· Provide administrative support to sale team such as copy, certify of copy, notary public for RA documentation for tender
· Liaise and work closely with the related authorities such as Medical Equipment and Construction Department (MOH)
· Monitoring changes of regulations for product registration and importation requirements and providing suggestions and implement effective ways to manage the changes
· Other ad-hoc duties as assigned by the management

*Liaises With
· Global RA to manage product and application related matters, technical support, updates and enquiries.
· Regulatory affairs department of Roche affiliates
· Relevant Internal Team members including Sales, Marketing, Finance, logistics, Service, Application and other departments/areas as required
· Internal logistics team for product registration and importation related matters
· Vietnam Ministry of Health (DMEC)
· Culture and information service
· Customs
· Trade Ministry
· Notarization offices
· Suppliers: DKSH, Printing companies, …
· Consultant companies (KPMG, Mac Kenzie…)

*Requisite Qualification & Experience Qualification
· Bachelor Degree in Health/Science/Medical Technology disciplines

*Experience
· Multi-national companies experience is preferred
· At least 3 years’ managerial experience in regulatory affairs team in similar industry
· Clinical laboratory experience will be added advantage

*Skill
· Proficient in both English and Vietnamese (spoken & written)
· Personal Computer Skills (Microsoft Office Application)
· Effective Communication Skill
· Good Interpersonal Skill
· Creative Problem Solving Skill
· Customer Handling Skill
· Time Management Skill
· Ability to work independently and as team player
· Self-initiative and Proactive
· Presentation and Training Skill
· Project Management Skill
· Team Management Skill

- In accordance with Company's Policy

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