Job Title: Regulatory Affairs Officer (2 Jobs)
Organisation: Dei BioPharma Ltd
Duty Station: Matugga, Wakiso, Uganda
About the Company:
Dei BioPharma Ltd is a biotech and pharmaceutical research firm duly incorporated in Uganda, specializing in the development and manufacture of innovative medicines and vaccines. Our state-of-the-art manufacturing facility, situated in Matugga, Wakiso district, Uganda, shall produce high-quality medicines across a wide range of therapeutic areas.
Job Summary: The Regulatory Affairs Officer is responsible for preparing, reviewing, and submitting dossiers for registration and post-approval variations of pharmaceutical products to national and international regulatory authorities, including NDA Uganda, WHO PQ, and other global agencies.
The role supports regulatory strategy, lifecycle management, and ensures timely approvals in compliance with regulatory requirements and internal procedures. The officer will maintain regulatory documentation, monitor evolving guidelines, support audits, and collaborate with R&D, QA, and production teams to ensure regulatory readiness. The ideal candidate should have strong knowledge of Common Technical Document (CTD) formats, regulatory filing procedures, and experience with GMP-compliant dossier submissions.
Key Duties and Responsibilities:
- Prepare and compile registration dossiers (Module 1–5) in CTD/ eCTD format for new products and variations.
- Coordinate regulatory submissions to NDA and other global agencies, ensuring completeness, accuracy and compliance.
- Monitor regulatory guidelines and changes in requirements; ensure timely updates to internal stakeholders.
- Maintain and archive all regulatory files and correspondence in compliance with data integrity and traceability standards.
- Support regulatory responses to deficiency letters, renewals, packaging updates and technical queries.
- Liaise with cross-functional teams to gather data for regulatory submissions including product development, QC, and QA.
- Assist in the preparation for GMP inspections and regulatory audits including generation of compliance documentation.
- Track submission timelines, approvals and renewals to ensure continued product registration.
- Provide regulatory input into artwork reviews, labels and promotional material compliance.
- Support internal regulatory training and awareness programs to enhance compliance culture.
Qualifications, Skills and Experience:
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related biomedical discipline. Postgraduate certification in Regulatory Affairs is an added advantage.
Experience and Competencies:
- Minimum of 3–5 years’ experience in regulatory affairs within a pharmaceutical manufacturing environment.
- Strong knowledge of CTD structure, local and international regulatory frameworks (NDA, WHO, EAC, SRA).
- Experience in dossier preparation, variation filings, renewals and regulatory correspondence.
- Excellent organizational and time-management skills with a focus on accuracy and compliance.
- Effective communication and ability to work cross-functionally with technical teams.
- Proficiency in Microsoft Office and regulatory document management systems.
How to Apply:
All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Human Resources Manager)
All Application documents should be merged as one document in PDF or .DOC / .DOCX, which should not exceed 10MB
Applications should be sent by email to [email protected] with the JOB TITLE IN THE SUBJECT LINE.
Should you not hear from us within twenty-one (21) days from the closing date of this advertisement, you may consider your application to be unsuccessful.
Deadline: 12th May 2025 by 5:00 PM
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