Regulatory Affairs Specialist - DGDA Submissions
Job Description
Title: Regulatory Affairs Specialist - DGDA Submissions
Company Name: Eagle Eye Limited BD
Vacancy: 2
Age: At least 22 years
Job Location: Dhaka
Salary: Tk. 80000 - 160000 (Monthly)
Experience:
- At least 2 years
- The applicants should have experience in the following business area(s): Multinational Companies, Market Research Firms, Audit Firms /Tax Consultant, Cosmetics/Toiletries/Personal Care, Group of Companies, Call Center, Research Organization, Individual/Personal Recruitment
Published: 2025-12-06
Application Deadline: 2025-12-16
Education:
- Bachelor of Pharmacy (B.Pharm)
Requirements:
- At least 2 years
- The applicants should have experience in the following business area(s): Multinational Companies, Market Research Firms, Audit Firms /Tax Consultant, Cosmetics/Toiletries/Personal Care, Group of Companies, Call Center, Research Organization, Individual/Personal Recruitment
Skills Required:
Additional Requirements:
- Age At least 22 years
Responsibilities & Context:
We are a leading international generic pharmaceutical company in Bangladesh, operating a sterile injectable manufacturing facility compliant with US FDA, EU GMP, and WHO standards. We are rapidly advancing multiple high-value complex injectable product pipelines for both local and international registrations, with a strong focus on the DGDA new drug submission for Tirzepatide and other GLP-1 injectable products.
To ensure timely DGDA approvals and parallel ANDA preparations for global markets, we sincerely invite experienced Regulatory Affairs professionals familiar with DGDA regulations to join us and collaborate closely with R&D, QA, and Manufacturing teams to accelerate product launches.
Key Responsibilities
Lead full regulatory submissions of generic drugs (especially sterile injectables) to the Directorate General of Drug Administration (DGDA), including NDA preparation, follow-up responses, and variation filings.
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Prepare, review, and submit DGDA-required dossiers (administrative documents, CMC, nonclinical, clinical, labeling/leaflet, etc.) ensuring compliance with the latest DGDA guidelines and formatting requirements.
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Take primary ownership of the Tirzepatide injectable DGDA submission, including regulatory strategy, dossier preparation, and query responses.
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Maintain effective communication with DGDA officials, track submission progress, attend meetings, and provide timely responses to inquiries.
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Support parallel preparation of international dossiers (ANDA Module 3, CTD format) for future EU/WHO submissions.
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Manage product lifecycle requirements including variations, renewals, and GMP compliance documentation.
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Coordinate with cross-functional teams (R&D, QA, Production) to ensure accuracy and consistency of technical content.
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Monitor regulatory updates from DGDA, ICH, FDA, and EMA; provide internal guidance to ensure compliance.
Qualifications
Required:
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Law, or related fields (graduates from Bangladeshi universities such as Dhaka University or North South University, or internationally accredited universities).
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Minimum 2 years of hands-on experience in DGDA submissions for new drugs/generic drugs, familiar with the DGDA online submission system and latest guidelines.
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Strong understanding of regulatory requirements for generic drug submissions, especially CMC documentation for sterile/aseptic injectables.
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Strong English reading and writing skills (required for dossier preparation and communication with international partners).
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Detail-oriented, responsible, and able to work under time-sensitive deadlines.
Preferred (Highly Advantageous):
Experience with DGDA or international submissions for Tirzepatide, Semaglutide, or other GLP-1 injectable products.
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Experience with ANDA, EU variation filings, or WHO Prequalification submissions.
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Proven experience handling DGDA queries, on-site inspections, or expedited review cases.
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Familiarity with eCTD format, Module 3 CMC authoring, or BE study documentation.
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Relevant certifications (e.g., RAC, DGDA regulatory training) or publications in regulatory affairs.
What We Offer
Competitive Salary (based on experience):
Bachelor’s degree with 2–5 years experience: BDT 80,000–120,000/month
Master’s degree or 5+ years experience: BDT 120,000–180,000+/month
(Higher packages available for candidates with DGDA injectable or Tirzepatide submission experience; includes performance bonus, year-end bonus of 2–4 months, and Eid bonuses.)
How to Apply
Please send your English CV (with recent photo), expected salary, personal statement, and any relevant portfolio materials (e.g., DGDA dossier table of contents, list of successful submissions; confidential information may be removed).
Job Other Benifits:
Comprehensive Benefits:
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Medical insurance (including family coverage) and personal accident insurance
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Double Eid bonuses (Eid-ul-Fitr & Eid-ul-Adha)
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Annual salary review and performance/project bonuses
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Paid annual leave, sick leave, and parental leave above legal requirements
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Free meals, transportation allowance or company shuttle
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Annual health check-up, company trips, and team events
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Professional regulatory training and international development opportunities (India, EU, US, etc.)
Employment Status: Full Time
Job Work Place: Work at office
Company Information:
Gender: Male and Female can apply
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Category: Pharmaceutical
