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Job Title REGULATORY AFFAIRS SPECIALIST
Country Vietnam, Ha Noi
Position Type Regular
Immediate Superior (title) RA Team Leader
Immediate Subordinates (title) None
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Key Job Purpose:
- Dossier preparation & product registration submission to Vietnam Ministry of Health (MOH), leading to timely introduction of new products as well as Renewal/Change Notification.
- Provide regulatory support, update, advisory & knowledge sharing to other departments, distributors and Sysmex Asia Pacific in order to remain in compliance with the government regulatory requirements in Vietnam.
- Serve as the primary contact between the company and regulatory agency-MOH. Maintain and develop relationship with MOH and relevant organization.
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Summary of Functional Duties & Responsibilities:
- Contact to Sysmex Asia Pacific regulatory affair department to get necessary documents for Sysmex Vietnam.
- Prepare & submit product registration documentation & other relevant licenses’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Vietnam.
- Notify and update MOH of any change of particulars/documents related to product registration.
- Ensure changes to the approved products are timely submitted to MOH as required.
- Maintain product registration record and product registration database to ensure proper documentation and record filing.
- Act as a contact between the company and the MOH, maintaining and developing relationships with the MOH and relevant organizations
- Compile all relevant legal requirements from the departments; maintain and update master list of regulation requirement. Coordinate with the departments to assess compliance with the regulations.
- Support other departments in all regulatory related areas, legal compliance matters if required.
- Prepare and manage sub-labels according to regulation.
- Manage translation of registration document as package insert, instruction for use, registration documents…
- Read, update and follow company's standard operating procedures and guidelines in daily work.
- Support Managers/Supervisor to make, review and improve standard operating procedures and guidelines.
- Establish procedure/work instructions of RA department according to supervisor‘ instruction.
- Participate in the company’s regular audits.
- As a company representative, working with legal consultants to advise/handle on the company's legal matters (legal contracts, business license, investment registration license…)
- Join meeting & training according to Manager/ Supervisor’s instruction.
- Any other duties as may be assigned.
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Authorize :
- To use equipment and facilities of the Company to serve the purpose to complete the task.
- To enjoy the full benefits stipulated in the labor contract, labor agreement and labor law.
- To refuse to perform the tasks assigned by Manager/ Superiors which not in conformity with the law.
- To co-operate with relevant departments to carry out daily works under the provisions of the Company.
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Job Specification :
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Minimum Education Required
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Degree in Medical science, law or equivalent
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Minimum Experience Required
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Min 4 years relevant working experience
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Skills and Knowledge Required
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PC literate, Good English in Speaking, Reading, Translation, Good communication.
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Attitude Required
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Hardworking and careful, positive mindset of customer satisfaction, teamwork and compliance
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Knowledge Desired but not Essential
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Biomedical or Healthcare or Law
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Travel Requirement
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Flexible to respond to company request for company, regional training/meeting
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Key Competencies :
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Good
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V. Good
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Excellent
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1.
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Plans and Organizes Effectively
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Ö
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2.
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Produce Quality Work-Meticulous & meet deadline
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Ö
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3.
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Reliability
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Ö
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4.
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Effective time management
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Ö
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5.
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Communicates effectively
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Ö
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6.
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Positive learning attitude & quick learner
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Ö
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7.
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Analytical ability and coves problems
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Ö
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8.
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Collaborates with others and teamwork
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Ö
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9.
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Customer focused
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Ö
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10.
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Project management
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Ö
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11.
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Decision Making
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Ö
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Competencies are expected for this position as show in above specific level. These competencies will be evaluated every year with Performance Appraisal review.
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