Head of Regulatory Affairs

Job Description

Title: Head of Regulatory Affairs

Company Name: Fortune Medical System Limited

Vacancy: 1

Age: Na

Job Location: Anywhere in Bangladesh, Gazipur (Sreepur)

Salary: Negotiable

Experience: --

Published: 2026-04-06

Application Deadline: 2026-04-30

Education:

Requirements: --

Skills Required:

Additional Requirements:

Responsibilities & Context:

Job Summary:

We are looking for a competent and detail-oriented person to support regulatory activities for both pharmaceutical and medical device products. The candidate must have strong knowledge of regulatory requirements, documentation, and submission processes in compliance with DGDA and international guidelines.

Key Responsibilities:

·       Obtain manufacturing license and MA from DGDA.

• Prepare, compile, and submit regulatory dossiers for pharmaceuticals and medical devices.

• Handle product registration, renewal, and variation submissions to DGDA and other regulatory authorities.

• Ensure compliance with local and international regulatory requirements (DGDA, US FDA, EU, MDR, WHO).

• Coordinate with QA, production, and R&D teams for regulatory documentation.

• Maintain and update regulatory documentation and databases.

• Review product labels, packaging materials, and promotional content for compliance.

• Support audit and inspection readiness related to regulatory affairs.

• Track regulatory changes and ensure timely implementation.

• Handle Drugs, Narcotics, BSTI & DPDT related all activities.

• Submit product price to DGDA for price approval and price re-fixation

• Obtain registration of import product and its timely renewal.

• Communicate with toll manufacturing company as & when required

• Assist in CE marking documentation for medical devices (if applicable).

• Communicate with regulatory authorities and respond to queries.