Executive/ Sr. Executive, IRA

Job Description

Title: Executive/ Sr. Executive, IRA

Company Name: Healthcare Pharmaceuticals Ltd.

Vacancy: --

Age: Na

Job Location: Dhaka

Salary: --

Experience:

• 1 to 4 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Bachelor of Pharmacy (B.Pharm)
• Master of Science (MSc) in Microbiology
• Bachelor of Science (BSc) in Genetics

M. Pharm/M.S. in Microbiology, Genetic Engineering from any reputed university.

• 1 to 4 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• 1-4 years of experience in a reputed organization in IRA/QA/QC/R&D is preferable.

• Excellent analytical ability & strong interpersonal skill.

• Advanced knowledge in MS Office.

• Excellent communication skills in English.

Healthcare Pharmaceuticals Ltd. is one of the leading pharmaceutical companies in Bangladesh, certified by the international pharmaceutical regulatory authorities like EU GMP, TGA (Australia), NPRA (Malaysia), MCAZ (Zimbabwe). TFDA (Tanzania), EU GMP etc. To support our expansion program, we are looking for candidates who are interested to join our team for the mentioned position:

Job Responsibilities:

• Prepare, review, and compile technical documents in CTD/ACTD format, including query responses, in compliance with country-specific regulatory requirements.
• Keep abreast of international regulatory legislation, guidelines, and customer requirements to ensure ongoing compliance and timely submission.
• Coordinate effectively with MAH, Business Counterparts, IBD, R&D, QA, and SCM to ensure smooth regulatory submissions and project execution.
• Conduct regulatory gap analysis and risk assessment to identify potential compliance issues and implement appropriate corrective and preventive actions (CAPA).
• Ensure effective product life cycle management by handling renewals, variations, labeling updates, and other post-approval regulatory activities

Job function: International Regulatory Affairs

Location: Head Office