Regulatory Affairs Assistat Manager- HCM- Urgent

Job Ref.
: Pharmaceutical
: VN, Ho Chi Minh
Salary range
: $1600- $1800
Job Type
: Permanent full-time

Job description

Job Description

1. Demonstrates knowledge of the product dossier preparation and registration process for Vietnam by obtaining timely product registrations and/or corresponding commercialization permits.

2. Effectively interacts and communicates by e-mail, fax, telephone and conference calls with attorneys, consultants, manufacturers and other departments on an everyday basis with relation to product registrations and their maintenance.

3. Assists with obtaining the legal review of concept formulas to determine ingredient acceptability and appropriate product classification in Vietnam.

4. Develops new printed components with label & artwork and completes regulatory review of the final artwork to ensure compliance to Vietnam regulations.

5. Prepares technical dossiers for individual products to be reviewed and evaluated by country officials for product approval. Requests and prepares supporting technical and non-technical data from manufacturers, internal database system, technical library and various departmental sources as and when required.

6. Initiates and drives changes for items (raw materials, formulas, printed components, SKU’s) through the database system. Responsible for confirming formula and label acceptability, as well as the receipt of necessary licenses, prior to requesting the release of product.

7. Prepares concise reports of all varieties through the database system. Responsible for adding and updating product & regulatory data in the database system. Assists with the validation of data for Vietnam, for use in all reports and queries.

8. Maintains and renews existing licenses for all products in Vietnam in a timely manner.

9. Keeps abreast of latest developing regulatory issues and communicates those issues to management.  Also keeps abreast of issues affecting existing in-country products and properly informs management and proposes solutions.

10.Carries out all responsibilities in an honest, ethical and professional manner.

Job Requirements

1. Bachelor’s degree in nutrition, biology, chemistry, food science, pharmaceutical science or related field.

2. At least 5 years related working experience in food/food supplement/pharmaceutical/cosmetics industry.

3. Thorough understanding of regulatory environment and product registration requirements

4. Good command of both written and spoken Vietnamese and English.

5. Detail-oriented with the ability to analyze complex technical data and develop recommendations and solutions.

6. Excellent organizational skills and ability to multitask

7. Ability to interact effectively at all levels and across diverse cultures.

8. Ability to be an effective team member and to handle project leadership responsibly.

9.Ability to adapt to a fast paced setting and evolving goals and objectives

10.PC skills (email, word-processing, spreadsheets, etc.)

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