Regulatory Affairs Executive (Vietnam)

- Reports to: Regulatory Affairs Manager
*PURPOSE OF THE ROLE:
- The Regulatory Affairs Executive support RA manager to the implementation of global regulatory strategy in Vietnam and is responsible for new drugs registrations and maintenance of the current product Registrations in the country as appropriate.

*KEY RESPONSIBILITIES:
• Collaborate with the appropriate global regulatory affairs (GRA) functions (Regions, Reg-CMC, Reg Ops), and related local stakeholders (medical/ marketing depatments) for the product license maintenance and new drugs registration according to the agreed timeline
• Work with GRA/ related local stakeholders to obtain all required information/documents for the drug registration
• Create / maintain dossier/technical files in the good order. Establish and maintain system for tracking changes in documents submitted to local authorities/ agencies.
• Ensure thorough follow-up with drug registration progress, and initiate actions accordingly until the final results.
• Maintain aclear documentation of weekly discussion and agreements with GRA / related stakeholders
• Provide regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
• Provides periodic Regulatory Updates to the business
• Support RA manager to monitor changes in the Vietnam regulatory environment, both general and specific to the therapeutic area , and advise the global regulatory strategy accordingly.
• Communicate key issues to senior management and to GRA as appropriate.
• Review of all necessary PV reports and timely submissions to regulatory authorities and to Italfarmaco Group if required.