BDJOBS: Jobs site in Bangladesh | jobs in Bangladesh | Jobs In Dhaka

Category : Pharmaceutical & Medical

Job Summary

Published On : May 27, 2025
No. of Vacancies : Not Specific
Job Type : Full Time
Job Level :
Experience : At least 6 years
Location : Narayanganj (Siddirganj)
Salary Range:
Negotiable
Application Deadline : Jun 18, 2025

Shortlist this job

Share by Email

Print this job

View all jobs of this company

Report this job

Sr. Executive/Assistant Manager, QA (Foreign Regulatory Compliance)

A Reputed Pharmaceutical Company

View all jobs of this company

No. of Vacancies

Not Specific

Job Description / Responsibility

To prepare registration dossiers of the drug product as per Common Technical Document (CTD), ASEAN Common Technical Document (ACTD), and the General format (country-specific) for the registration of Pharmaceutical Products with the regulatory agencies of different countries.
To review Standard Testing Procedure (STP), Standard Operating Procedure (SOP), Batch Documents, APQR Report, Process validation Protocol & Report, API Drug Master File, Test & Analysis reports of Finished product, Raw Material, and Packing Material for dossier preparation.
To prepare and review module-1 of CTD as per the requirements of foreign regulatory agencies, Quality Overall Summary-Product Dossier (QOS-PD) Word template, and Quality Information Summary-Product Dossier (QIS-PD) format of different foreign regulatory agencies.
To prepare Certificate of Analysis (COA) of Raw Material, Packaging Material & Finished Product for export dossier and during shipment of the specific product.
To provide documents, information and clarification following the Notice of Deficiency (NOD) / Query from the foreign regulatory agencies.
Coordinate and correspond with Quality Control, Production, R&D, International Marketing, Commercial department and different regulatory authorities.

Educational Requirements

Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), Master of Science (MSc) in Chemistry

Experience Requirements

At least 6 years

Additional Job Requirements

Location

Narayanganj (Siddirganj)

Salary Range

Negotiable

Job Source

Bdjobs.com.bd Online Job Posting

Applicant must enclose his/her Photograph with CV.

Application Deadline : Jun 18, 2025

about bdjobs

job seekers

employers

for job announcement