Regulatory Affairs Supervisor (Ha Noi)
Ha Noi
Job Title: Regulatory Affairs Supervisor
Department: Regulatory Affairs
Summary:
_ Responsible for the coordination and preparation of documents for regulatory submissions as well as for reviewing as per country and corporate requirements
_ Assists country RA Manager in reviewing administrative, technical and scientific documents required for submission in support of the company’s products.
_ Assist country RA Manager in setting up RA registration strategy to ensure the RA’s goal to meet country goal
Essential Duties and Responsibilities.
· Compile regulatory documents for submission according to local requirements in countries of responsibility. This involves liaising and coordinating with 3rd party distributors in Vietnam.
· Ensure all submissions, both planned and on-going, are logged and tracked regularly.
· Compile and prepare responses to questions from regulatory authorities on submitted documents. Interaction with
Officers to ensure sufficient responses on time.
· Working with Regional and Global RA colleagues independently to review and response to Vietnam MOH’s queries.
· Liaise with regional and global regulatory colleagues to answer queries or requests from business and/or other functions including completion of tender documents
· Responsible for maintaining product labels and package inserts of registered pharmaceutical products as well as medical devices. This includes liaising with global regulatory colleagues to ensure product labels and package inserts updates are submitted to health authority in a timely manner.
· To be the main responsible person for development and implementation Vietnamese labels and inserts, corporate with SC/QA/3PL to ensure no supply gaps due to local processes in re-labelling processes.
· To Support related submission required for tender classification, Price declaration …as per requested.
· Review, edit and proof-read regulatory documentation where required
· Archive and maintain regulatory files in a format consistent with local health authority and corporate requirements
· Training Regional and Global RA colleagues about Vietnam updated new regulation for enrich their awareness of
Vietnam’s regulatory requirements to support Vietnam’s RA team.
· Perform other administrative work and necessary activities related to regulatory affairs
Key Result Areas (KRA’s) & Key Performance Indicators (KPI’s)
(KRA: The business goal to be achieved.)
(KPI: Translate the KRA into a performance management indicator/objective.)
KEY RESULTS AREA (KRA)
KEY PERFORMANCE INDICATOR (KPI)
1. Business Results
Effectively support to all BUs in achieving good results of Regulatory Affairs activities within budget and in line with approved plans.
2. Ongoing Professional Development
Actively participate and successfully complete
(captured in ISO Train) corporate training programs.
3. Reference partners
Gain customer acknowledgment as a partner they can rely on for knowledge, skill and resources
4. Compliance with internal Baxter SOP’s and
compliance regulations
100% compliance
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Company Size:
Industry:
Pharmaceutical
Job Category:
Legal
Job Type:
Location:
Ha Noi
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