Job Description

Title: [Urgent Hiring] Local R&D and DGDA Registration Engineer – Tirzepatide Injection Project

Company Name: Eagle Eye Limited BD

Vacancy: 1

Age: 22 to 35 years

Job Location: Dhaka

Salary: Tk. 100000 - 150000 (Monthly)

Experience:

Published: 2025-12-09

Application Deadline: 2025-12-19

Education:

Requirements:

Skills Required:

Additional Requirements:

• Age 22 to 35 years

Company: Leading Chinese Injectable Generics Group (Tirzepatide full-formulation industrialization project in progress)

We are one of China’s earliest and leading enterprises in the GLP-1/GIP dual-agonist field. Our Tirzepatide injection has successfully passed China’s consistency evaluation and is already commercialized in the domestic market.
Our Dhaka-based factory is rapidly advancing multiple Tirzepatide dosage strengths (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) for both pre-filled pen and cartridge formats, targeting local Bangladesh approval by 2026 and future export to the US/EU markets.

We are now urgently recruiting core local R&D and regulatory specialists in Bangladesh to lead the accelerated DGDA approval for our Tirzepatide products.

Job Responsibilities

(100% focused on the Tirzepatide project)

1. Lead the full Marketing Authorization submission process for Tirzepatide injection (including solvent) to DGDA.

2. Prepare complete local CTD documentation (Modules 1–5) for peptide injections, including:
   • API synthesis route and peptide quality standards (DMF)
   • Formulation & manufacturing processes for pre-filled pens/cartridges; compatibility & stability studies
   • Aseptic process validation, cold-chain studies, transport validation
   • BE waiver justification (based on China CE data + Q1/Q2/Q3 sameness)

3. Directly communicate with DGDA Biologicals Division; respond to queries, manage site inspections.

4. Oversee 3 commercial-scale validation batches, product release, and long-term stability studies.

5. Prepare local technical data required for future WHO PQ and EU regulatory variations.

6. Coordinate daily with the peptide development team at China Headquarters to ensure full technical alignment.

Requirements (Strict Mandatory Conditions)

1. Bangladeshi national; degree in Pharmacy, Pharmaceutics, Biotechnology; Master’s preferred.

2. 5+ years of R&D/Regulatory experience in injectables, with at least ONE of the following:
   • Successfully led DGDA approval for Semaglutide, Liraglutide, or Dulaglutide peptide injections; OR
   • Led DGDA approval for 2 or more sterile injectable products (oncology, antibiotics, or general injectables).

3. Experience in major Bangladeshi pharmaceutical companies preferred (Incepta, Beximco, Square, Beacon, Healthcare, Eskayef, etc.).

4. Excellent English proficiency – capable of independently drafting full CTD dossiers and communicating directly with DGDA officers.

5. Strong understanding of peptide cold-chain requirements, pre-filled pen compatibility studies, and aseptic filling processes.

Compensation (Top of Bangladesh Market)

• Monthly Salary: BDT 100,000 – 150,000
  (Higher negotiable for candidates with GLP-1 peptide experience)