Support the product regulatory activities and implementation of regulatory affairs strategies. Adapt regulatory affairs strategy and ensure Compliance to internal and external regulatory process and standard ASEAN
Achieve registration of Company products promptly and efficiently with necessary status report
Facilitate the approval and registration processes under GDPMD compliance
Ensure product registration renewal, line extension, and any change of registered particulars are achieved in a timely manner with continual update to supervisor
Coordinate on management of new and existing product registration, RA projects and product launch
- Regulatory Compliance
Liaise closely with regulatory and manufacturing groups to ensure our products, including labeling, artwork and the finished products, are complied with local regulatory requirements and guidelines
Collaborate with relevant internal counterparts to ensure our products on the market are complied with current registration
Monitoring and tracking product changes, new regulation or standard implementation
Follow necessary approval procedures in updating Local Product Documents (LPD) as per local regulatory requirements and SOP
Ensure the database in Global Regulatory System (GRS) is up to date and meet the requirements according to SOP
Maintain necessary record-keeping on regulatory related issues
Dealing with product complaints, recall and quality audit
Provide supporting documents for the government/Hospital Authority tender applications
Provide supporting documents for importation and tender applications
Develop RAQA plan and implement plan to maximize growth and profit in the assigned region.
Develop a thorough understanding of the local context by attending regional conference and regulatory groups to gather market intelligence and formulate strategies to meet various ASEAN countries need.
Provide support to distributors, ensure quality services on regulatory documents delivery and maintain good relationship
Work with marketing team to ensure regulatory timeline are align with the marketing and launch plan.
Adhere to all company policies, procedures, and business ethics codes.
Manage a team of RAQA personnel.