Regulatory Affairs Professional

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

Roles & Responsibilities

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

High
60%
Regulatory Compliance

• Create and manage end-to-end local medical devices packaging and labelling(Artworks) to assure the compliance with local regulations

High
10%
Quality Affairs

Medical Device Qualified Person

• Registered QP for Device under Bausch Lomb Korea s)

Labelling Management

• Manage local labeling for new and existing products to comply with regulatory requirements

Registered administrator for UDI system

• Registration of UDI-DI for medical devices in the UDI system

Quality Support

• Manage local QC testing of drugs/Quasi-drugs with local QC lab

High
30%

Requirements

Education

Descriptions

Academic

Degree

• A minimum of Bachelor’s degree in scientific discipline is required.

Experiences

• A minimum of 3 years of working experience in regulatory affairs or quality affairs of pharmaceutical/or medical device company is required

Bausch Health is an EEO/AA employer M/F/D/V.