Regulatory Affairs Specialist (Contract Manufacturing & Export)

Job Description

Title: Regulatory Affairs Specialist (Contract Manufacturing & Export)

Company Name: Eagle Eye Limited BD

Vacancy: 5

Age: 22 to 30 years

Job Location: Anywhere in Bangladesh

Salary: Negotiable

Experience:

• 1 to 4 years
• The applicants should have experience in the following business area(s): Multinational Companies, Market Research Firms, Audit Firms /Tax Consultant, Manpower Recruitment, Cosmetics/Toiletries/Personal Care, Group of Companies, Call Center, Research Organization, Individual/Personal Recruitment

• Bachelor of Pharmacy (B.Pharm)

• 1 to 4 years
• The applicants should have experience in the following business area(s): Multinational Companies, Market Research Firms, Audit Firms /Tax Consultant, Manpower Recruitment, Cosmetics/Toiletries/Personal Care, Group of Companies, Call Center, Research Organization, Individual/Personal Recruitment

• Age 22 to 30 years

Dhaka, Bangladesh

Employment Type: Full-time

Company Overview:

We are a Hong Kong-headquartered professional pharmaceutical wholesale and trading company specializing in global generic drug supply chain management. We are actively seeking high-quality pharmaceutical manufacturing partners in the Dhaka region for contract manufacturing (Contract Manufacturing / Loan License) to produce high-quality generic drugs for export to markets in Asia, Africa, and other international regions. We are looking for a talented professional with in-depth knowledge of Bangladesh’s pharmaceutical export regulatory processes to join our local team in Dhaka and support the smooth execution of contract manufacturing and export operations.

Key Responsibilities:

• Manage the complete registration application process for our generic drug products with the Directorate General of Drug Administration (DGDA) in Bangladesh, including new drug registrations, variation applications, and renewals.

• Coordinate and oversee contract manufacturing collaboration projects between our Hong Kong headquarters and local Bangladeshi pharmaceutical manufacturers, ensuring all production complies with DGDA export-oriented requirements.

• Prepare and follow up on export-related regulatory documents, including GMP certificate applications, Certificate of Pharmaceutical Products (CPP), Free Sale Certificate (FSC), and export permits (Export License / Form 8, 9A, 10A, etc.).

• Assist partner manufacturers in preparing and submitting technical files and dossiers (primarily in CTD/ACTD format) required by DGDA, with a focus on export-only products.

• Serve as the primary liaison with DGDA and other government authorities (e.g., Drug Testing Laboratories – DTL), handling query responses, supplemental data requests, and preparation/accompaniment for site inspections.

• Monitor the latest changes in Bangladesh pharmaceutical regulations, particularly the Drugs and Cosmetics Act 2023, contract manufacturing guidelines, export-specific provisions, and alignment with international standards (e.g., WHO GMP requirements).

• Support regulatory filing of contract manufacturing agreements, including Letters of Authorization, product specification confirmation, and batch release documentation.

• Maintain regulatory files for all export products, track certificate validity, and ensure uninterrupted production and export processes.

• Coordinate cross-functionally (with Hong Kong headquarters, partner manufacturers’ QA/production/business teams) to ensure timely document submission and compliance with importing countries’ requirements.

• Assist as needed with import permits for raw materials and export customs clearance matters.

Qualifications & Requirements:

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related field (B.Pharm / M.Pharm preferred).

• At least 2 years of experience in pharmaceutical Regulatory Affairs, with a minimum of 2 years of hands-on DGDA new drug registration experience (including full new drug registration, variation applications, and renewal processes; candidates with independent experience in dossier submission, query responses, and site inspection accompaniment preferred).

• Prior experience with DGDA export permits, contract manufacturing, or toll manufacturing projects is highly preferred.

• Strong familiarity with the Drugs and Cosmetics Act 2023, DGDA contract manufacturing guidelines, GMP certificate application processes, CPP/FSC procedures, export permit processes, and key site inspection focus areas.

• Proven track record of direct interaction with DGDA on export-related applications, query responses, or accompanying site inspections preferred.

• Excellent English proficiency (reading and writing essential), with the ability to independently draft professional technical documents, respond to DGDA queries, and prepare English contract annexes.

• Native or fluent Bengali speaker.

• Detail-oriented, highly responsible, with strong stress resilience, excellent document management, timeline control, and cross-departmental coordination skills.

• Able to work independently while collaborating efficiently with the Hong Kong team and local manufacturing partners.

What We Offer:

• Competitive salary (negotiable based on experience, including performance bonus)

• Year-end bonus/festival allowances

• Comprehensive social insurance, medical insurance, and other benefits

• Professional training opportunities (including updates on international regulatory affairs)

• Modern office environment with a flexible work atmosphere

• Opportunity to join a fast-growing cross-border pharmaceutical supply chain team and participate in multi-country export projects

• T/A
• Festival Bonus: 2