Executive, Regulatory Affairs

Job Description

Title: Executive, Regulatory Affairs

Company Name: Gaco Pharmaceuticals

Vacancy: 1

Age: 25 to 35 years

Job Location: Dhaka

Salary: Negotiable

Experience:

• 2 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Bachelor of Arts (BA)
• Master of Arts (MA)

• 2 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age 25 to 35 years
• Only Male

• Prepare, compile, and submit product registration dossiers to DGDA for new drugs, generics, and imported medicines.
• Manage variations, renewals, and post-approval changes according to regulatory guidelines.
• Follow up with DGDA to ensure timely approvals.
• Ensure compliance with Bangladesh Drug Act, DGDA regulations, and international guidelines (ICH, WHO, etc.).
• Keep updated with changes in local and global drug regulations.
• Advise R&D, production, and marketing teams about regulatory requirements.
• Review and approve labels, package inserts, leaflets, and outer cartons to meet DGDA labelling guidelines.
• Ensure that all promotional materials comply with regulatory standards
• Work closely with formulation development, quality assurance, production, and marketing teams.
• Provide regulatory input during product development to ensure early compliance.
• Maintain official correspondence with DGDA and attend regulatory meetings when required.
• Respond to queries, objections, or deficiencies raised by regulatory authorities
• Maintain updated regulatory files and product registration databases.
• Archive all approval letters, licenses, and certificates for future reference.
• Prepare dossiers in CTD / ACTD format for export markets.
• Coordinate with overseas regulatory agencies and partners for product approvals abroad.
• Assist in collecting and reporting adverse drug reactions (ADR) as per DGDA requirements.
• Ensure post-marketing surveillance compliance.

• Mobile bill
• Salary Review: Yearly
• Festival Bonus: 2