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: 20 to 30 years

Job Location: Gazipur (Sreepur)

Salary: Tk. 15000 - 18000 (Monthly)

Experience:

• 1 to 2 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

• 1 to 2 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Age 20 to 30 years
• Only Male

• Both males are allowed to apply.

• Strong organizational skills and attention to detail for handling complex technical data.

• 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.