Head of Regulatory Affairs

Job Description

Title: Head of Regulatory Affairs

Company Name: Advanced Chemical Industries PLC (ACI)

Vacancy: 1

Age: Na

Job Location: Dhaka (Gulshan)

Salary: Negotiable

Experience: --

Published: 2026-08-11

Application Deadline: 2026-08-31

Education:

Requirements: --

Skills Required:

Additional Requirements:

Responsibilities & Context:

1. Ensure overall compliance with applicable DGDA regulations, guidelines, licensing requirements and regulatory standards.

2. Lead product registration, renewal, amendment/variation, price approval, DTL sample submission and other regulatory approval processes.

3. Ensure timely preparation, review and submission of registration dossiers, technical documents and responses to regulatory queries.

4. Maintain effective liaison with DGDA and other relevant authorities for registration, licensing, inspections, approvals and regulatory matters.

5. Coordinate with Product Development, QA, QC, Production, Marketing, SCM and other functions to ensure timely regulatory support across the product lifecycle.

6. Lead regulatory inspections, monitor changes in regulatory requirements, assess associated risks and recommend necessary actions to management.

7. Oversee regulatory requirements related to pharmacovigilance, adverse drug reaction reporting, product recall and market withdrawal, where applicable.

8. Lead and develop the Regulatory Affairs team and provide regulatory guidance for new products, projects and strategic business initiatives.