Mô tả công việc
•As assigned, gather, analyse and communicate internal and external regulatory intelligence
•Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
•Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with guidance from DRA Management
•As assigned, represent Affiliate Regulatory in cross-functional teams
•Adapt global product dossiers to local requirements
•Prepare and manage regulatory registration filings across product lifecycles. It includes the new registration/ extension/TRIC/ PI update/ VN make up or any variations
•Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs
•Ensure timely regulatory filings submissions and approvals
•Influence internal and external stakeholders for successful regulatory outcomes
Information and Documentation Management:
•Manage Affiliate regulatory activities on relevant Roche systems
S, interface portal, Q&A interface portal, CPP system, GRANT, COREMAP
•Local: Touchpoint, Report.
•Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
•Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities
•Ensure regulatory compliance for product released to market according to marketing
•Control, manage and develop the registration data: Record Decision, MA, approved PIs & artworks; approved indications... Control the CPP, GMP, trade mark certificate, power of attorney, plant master files of manufacturing for assigned products.
•Adverse Events Report: be responsible for reporting all available information of an Adverse Event within one business day of awareness
•Manage end-to-end local product packaging and labelling from a regulatory perspective
•Where applicable, review and approve promotional materials to provide regulatory input and guidance across the Affiliate
•Technical quality: Support Quality person to implement local quality SOP (if any)
•Independent decision: Routine activities for assigned products
-Listing Brand name: Prepare application for submission to list assigned products into the brand name list of MOH. Assist RA Manager to get approval/ lead tracking.
-Listing GMP: Prepare application for submission to list manufacturers/products into the GMP list of MOH for all manufactures. Assist RA Manager to get approval. Act as GMP coordinator to make sure GMP listing for products.
-Tender documents: as requested
-SIQ documents: as request
•Support local market access activities from a regulatory perspective
•Lead tender support
•Lead GMP listing