Regulatory Affairs Associate Manager (Healthcare)

The position reports to the Head of Regulatory Affairs Vietnam. Located in Hanoi.
Key responsibilities are as follows:
- For projects assigned, develop and provide input to the development of sound regulatory strategies and properly execute them. Elaborates risk mitigation plans that support the company's portfolio. Critically review regulatory submissions for portfolio.
- Act as functional expert on local/regional/global project teams for projects, interpreting issues and provide strategic input to project team on the application of local regulations, review processes and submission requirements.
- Perform and maintains all regulatory activities for assigned projects and products under responsibility.
- Tracking and push the submissions at HA with impacts; follow up the dossier status with Experts as deem necessary to be able to reach the targeted approval timeline.
- Develop and manages optimal labeling for all products throughout the product lifecycle in close alignment with global labeling group
- Review internally and submit HA of promotional material
- Monitor regulatory environment/local regulatory partners/stakeholders, assess impact on assigned portfolio and timely communicate to internal stakeholders. Works on mitigation plan to optimize submission strategies and maximize business benefit.
- Keeps close contact to the affiliates/ for exchange of regulatory requests and information regarding the allocated tasks
- Ensure compliance with local regulations and corporate policies and procedures.
- Documentation management: archiving, maintains and provides RA documents to relevant stakeholders
- Ensures timely and accurate data entry/maintenance into databases, online systems.
- Work closely with SNO Dept. for supply management.
- Work closely with QA department on product complaints, quality alerts
- Work with GDS on PSUR and PV activities