Regulatory Affairs Assistant (Contractor)

POSITION SUMMARY:

The Regulatory Affairs Assistant is to support the Regulatory Affairs Lead in all RA processes such as: NPL launches to the market within the timeline; ensure the compliance of in-line products with local regulation through the product renewal notification process, formulas update, labelling update. Support for costing of regulatory fees to tie up with operating expense and brands’ budget.

RESPONSIBILITIES

RESPONSIBILITIES

1. Support all RA processes to ensure compliance:

Support Product Notification process for NPL (New product launch) & EPL (Exist product launch) by :

• Check ingredients to ensure the compliance of formula.

• Prepare dossiers for notification submission & obtain notification approval and filing the Master Notification file.

• Collect data from Regone/PDS and share to agency for notification preparation & submission.

• Follow up closely with Drug Administration Vietnam (DAV) to update status of submitted notification.

• Request CFS & LOA for products.

• Update final name on CFS to master file.

• Check all data of products in RegOne /PDS/RDS systems and upload data to Regone systems.

• Manage product data in system, processing file, master file, Noti list…

• Connect with global team to collect supporting data for registration

• Register cosmetic sample for sample import.

Support Vietnamese labelling:

• Check & update new Vietnamese labelling to master file.

• Request APAC to create new content labelling (if any).

2. Administration tasks:

• Proceed payment to DAV and agency and proceed payment for vendor

• Follow up with those Authority to collect invoices.

• Provide notification number to stakeholder (internal team,….) when having any request.

3. Other tasks: as assigned by line manager.

Yêu cầu công việc

• Regulatory Affair experience > 2 years.

• University Degree or College Degree with major Biology Technology/ Chemical/ or relevant major.

• Good-looking appearance.

• Good in English (written & speaking).

• Good communication skills, written and verbal.

• Good organizational skills, time management and follow up skills.

• Able to prioritize and handle several tasks simultaneously.

• Excellent Computer office skills. (excel)

Quyền lợi

• Thưởng: Lương tháng 13
• Chăm sóc sức khoẻ: Chương trình chăm sóc sức khỏe dành cho nhân viên
• Nghỉ phép có lương: 14 ngày phép/năm