Executive-QA/ Regulatory Affairs(Product Dossier Preparation)
Job Description
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.
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.
Education
- Bachelor of Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
Additional Requirements
- Age 20 to 30 years
Both males and females are allowed to apply.
Strong organizational skills and attention to detail for handling complex technical data.