Executive-QA/ Regulatory Affairs(Product Dossier Preparation)

Job Description

Title: Executive-QA/ Regulatory Affairs(Product Dossier Preparation)

Company Name: The White Horse Pharmaceuticals Ltd.

Vacancy: --

Age: Na

Job Location: Dhaka (Motijheel), Gazipur (Sreepur)

Salary: Tk. 15000 - 18000 (Monthly)

Experience: --

Published: 2026-06-11

Application Deadline: 2026-07-11

Education:

Requirements: --

Skills Required:

Additional Requirements:

Responsibilities & Context:

• Compile, review, and prepare Common Technical Documents (CTD) and ASEAN Common Technical Dossiers (ACTD) for new product registrations and renewals.

• Ensure all technical documentation and dossiers strictly adhere to WHO ACTD guidelines and the specific regulatory requirements of target countries.

• Prepare and manage drug registration documentation tailored for international export markets, including Southeast Asia, South Asia, Africa, and South America.

• Maintain and update comprehensive product registration lists and track submission statuses.

• Coordinate with production, quality control, and R&D departments to gather accurate technical data, ensuring all product packaging data and formulation details are correctly documented.