Công Ty TNHH Nipro Sales Việt Nam tuyển dụng Chuyên viên đăng ký và quản lý chất lượng

Start your brilliant career as REGULATORY AFFAIRS SPECIALIST

At Nipro, you will take on some of the world’s most meaningful challenges, delivering critical insights and innovative solutions to help and contribute to Vietnam health care. Nipro is a corporation committed to provide a place for you to grow personally and professionally. If your goals include building a career at a company where pride, passion and individual initiative really matter, then Nipro is the place for you.

Responsibilities:
Register for import and export products
Manage new products related to: Renal care, Injection and infusion, Cardiovascular, Infection control:
Provide direction to Marketing, R&D, Supply chain Operations, and Sales to facilitate speed to market and to maintain compliance with applicable regulatory requirements.
Support documents for SC for clearances, and registrations with relevant authorities for products introduced in Vietnam (for example, registrations for cosmetics, infection control, food processing aids, products listed on conditional trading license).
Develop relationships with FDA, MoH, SoH, DAV and relevant Authorities:
Check & maintain product compliance documents and ensure continued regulatory compliance of existing products.
Provide translations, technical documents, knowledge of local regulation.
Support customer compliance inquiries as needed
Manage Distributorship, consultant on regulations, preparation of registration dossier
Communicate with relevant depts for product labeling compliance

Basic Qualifications:
Bachelor's degree of Biotechnology/ Pharmacy/Medicine/Doctor with 2+ years professional experience; having experience with manufacturing site/ MOH registration experience are preferred.

Work place:
NIPRO SALES VIETNAM CO. LTD.
Unit 15.06, 15.07, Floor 15, Viettel Complex Building, 285 Cach Mang Thang 8, W. 12, D.10