[SANTEN PHARMACEUTICAL] - Regulatory Affairs Executive

Qualification:
- Graduated from Pharmacy University
- Careful and self-disciplined.

Knowledge & working experience:
- Knowledge of products development process, eye diseases, ophthalmic products
- At least 01 experience in regulatory field 

Skill(s):
- Good at English specially translation and writing skills
- Having good office software skills

- Based on company policy

- eLearning training

Job objectives:
- Preparing and submitting registration dossiers in comply with MOH’s regulations and Regulatory plan 
- Developing artworks for submission and production/redressing
- Handling regulatory administrative tasks 
- Supporting Marketing & Market access teams in submission and following up related dossiers with MOH
Building and maintaining good relationship with relevant authorities.

Responsibilities:
- Preparing new registration, renewal, variation, importation permission and supplement dossiers in comply with manufacturer-based files, regulatory strategy and MOH’s regulations
- Submitting dossiers and following up with MOH as Regulatory plan
- Working with local agency/manufacturer for developing artworks for submission and production/redressing. Conducting artworks proof-reading to ensure accuracy and consistency of the artworks with registered dossiers and MOH’s approved versions. Ensuring no artwork mistake.
- Working with Business affairs team for preparation of Annual Report for submission to MOH as well as documentation for renewal of Company business license in Vietnam 
- Submitting and following up promotional material and symposium registration as requested by Marketing team
- Submitting and following up dossiers for brand name/GMP/API listing as requested by Market access team 
- Following up and getting hard copies of MOH’s response letters, approval letters, decisions, notification, requirement, regulations, Product licenses (MA), stamped artworks, etc..
- Filling and maintaining regulatory database both in hard copies and softcopy
- Handling other administrative tasks such as notarization, payments, etc..
- Completing relevant trainings of company, authorities, associations
- Handling other tasks as assigned by Regulatory Manager
- Receiving annual performance appraisal by Regulatory Manager of HCM Rep. Office