Senior Regulatory Affairs Executive (Hanoi)

Strategy/Planning:

• 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
• Filings:
• 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
• Global: GPRS, interface portal, Q&A interface portal, CPP system, GRANT, COREMAP
• Local: Touchpoint, Report.

Regulatory Compliance:

• 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 authorisations
• 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

Other:

• 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
• Supporting business:
  • 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

Project:

• Lead tender support
• Lead GMP listing