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
Published: 2025-08-14
Application Deadline: 2025-08-25
Education:
- Bachelor of Arts (BA)
- Master of Arts (MA)
Requirements:
- 2 to 3 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Skills Required:
Additional Requirements:
- Age 25 to 35 years
- Only Male
Responsibilities & Context:
- 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.
Job Other Benifits:
- Mobile bill
- Salary Review: Yearly
- Festival Bonus: 2
Employment Status: Full Time
Job Work Place: Work at office
Company Information:
Gender: Only Male can apply
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Category: Pharmaceutical
Interested By University
| University | Percentage (%) |
|---|---|
| National University | 9.16% |
| University of Asia Pacific | 4.20% |
| University of Development Alternative | 3.82% |
| University of Dhaka | 3.44% |
| North South University | 3.44% |
| State University of Bangladesh | 2.67% |
| Jahangirnagar University | 2.67% |
| Daffodil International University (DIU) | 2.29% |
| Jagannath University | 2.29% |
| Dhaka College | 1.91% |
Interested By Age Range
| Age Range | Percentage (%) |
|---|---|
| 20-30 | 56.49% |
| 31-35 | 42.37% |
| 36-40 | 0.76% |
Interested By Salary Range
| Salary Range | Percentage (%) |
|---|---|
| 0-20K | 9.92% |
| 20K-30K | 50.76% |
| 30K-40K | 26.72% |
| 40K-50K | 9.16% |
| 50K+ | 3.44% |
Interested By Experience Range
| Experience Range | Percentage (%) |
|---|---|
| 0 years (Freshers) | 4.96% |
| 0.1 - 1 years | 1.15% |
| 1.1 - 3 years | 38.17% |
| 3.1 - 5 years | 21.76% |
| 5+ years | 33.97% |
