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Regulatory Affairs Professional
☞ Bausch Health Companies Inc.
View: 116
Location: Busan
Category: R & D
Industry: Pharmaceuticals
Position: Entry level
Job type: Full-time
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Job content
Regulatory Affairs Professional (5427)Career Opportunities: Regulatory Affairs Professional (5427)
Requisition ID 5427 - Posted - APAC Reg Affairs - R&D - KR - Seoul - City (4)
Primary Goals
Primary Goals
- Proceed regulatory projects to obtain optimal registration of new products and to support the maintenance of existing products to meet the company business objectives and comply with regulatory requirements
- Support Quality Assurance activities to ensure high compliance of local activities to local regulations
R&R
Detailed Activities
Priority
(High/Medium/Low)
Task %
Product registrations
- Develop registration plans and submission strategies with guidance from RA MD team leader to meet the company business objectives
- Adapt global product dossiers to local requirements
- Prepare and manage regulatory registration filings across product lifecycles: New products, Variations, License Renewals, Device GMP certificates renewals
- Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs
- Hospital listing-Provide the documentation supports by request from commercial
60%
Regulatory Compliance
- Create and manage end-to-end local medical devices packaging and labelling(Artworks) to assure the compliance with local regulations
10%
Quality Affairs
Medical Device Qualified Person
- Registered QP for Device under Bausch Lomb Korea s)
- Manage local labeling for new and existing products to comply with regulatory requirements
- Registration of UDI-DI for medical devices in the UDI system
- Manage local QC testing of drugs/Quasi-drugs with local QC lab
30%
Requirements
Education
Descriptions
Academic
Degree
- A minimum of Bachelor’s degree in scientific discipline is required.
- A minimum of 3 years of working experience in regulatory affairs or quality affairs of pharmaceutical/or medical device company is required
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