job seekers
/
Job detail

Regulatory Affairs Supervisor (Ha Noi)

cap LP & Associates' client

location Ha Noi

post time Posted 28 months ago

 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

 

Fields marked with a * are required.

 
Resume *
No Available Resume? Please click here to create.

apply job

Fiend

Resume *

referedfriend

company detail


Over 500


Pharmaceutical


Legal


Full Time


Ha Noi


English


Supervisor


Vietnamese, English


144 Phung Van Cung Str., Ward 4, Phu Nhuan Dist., HCMC.


Ms. Lan Phuong


Tel: (+8428) 22532930 , Ext : 605


phuong.lan.nguyen@natopjobs.com.vn recruitment@natopjobs.com.vn lanphuong@lp-a.com.vn nhuthuyen@lp-a.com.vn