Assistant Manager (Regulatory Affairs)

Job Description

Title: Assistant Manager (Regulatory Affairs)

Company Name: Jayson Pharmaceuticals Ltd.

Vacancy: 1

Age: 25 to 35 years

Job Location: Dhaka

Salary: Negotiable

Experience:

• 5 to 10 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Herbal Medicine

• Masters
• Bachelor/Honors

• Bachelor/Honors, Masters

• Science background up to HSC is preferable

• 5 to 10 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Herbal Medicine

• Age 25 to 35 years

• The applicants should have experience in the field of above-mentioned Job Description / Responsibility

• Dossier preparation for product registration in local and export markets.

• Prepare, compile, and submit applications to DGDA and other regulatory authorities

• Prepare and submit applications for new and existing product price fixation and revision to DGDA

• Maintain communication with DGDA officials regarding product pricing approvals and notifications.

• Support new product development from regulatory perspective.

• Maintain updated records of all product registration files, renewals, and variations.

• Ensure timely submission of product registration renewals and variations.

• Coordinate with DGDA for approval, renewal, and post-approval changes.

• Ensure company compliance with local and international regulatory requirements.

• Assist in internal and external audits, inspections, and follow-up on corrective actions.

• Review artworks, labeling, and package inserts for compliance with regulatory guidelines.

• Coordinate with Production and QA to ensure correct implementation.

• Keep track of changes in drug regulatory policies, guidelines, and laws.

• Update management on new DGDA circulars or global regulatory changes.

• Liaise with R&D, QA, QC, and Production teams to gather technical data for submissions.

• Prepare export registration dossiers as per specific country requirements.

• Weekly 2 days holiday, yearly salary review, fully subsidize of Lunch facilities, yearly 02 Festival Bonuses.