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

Job Description

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

Company Name: A Reputed Pharmaceutical Company

Vacancy: --

Location: Narayanganj (Siddirganj)

Experience:
∎ At least 6 years

Published: 19 May 2025

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

Requirements:

Responsibilities & Context:
∎ 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.
∎ 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.

Workplace:
∎ Work at office

Employment Status: Full Time

Job Location: Narayanganj (Siddirganj)

Company Information:
∎ A Reputed Pharmaceutical Company

Read Before Apply: Please apply only who are fulfilling all the requirements of this job

Application Deadline: 18 Jun 2025

Category: Others