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Regulatory Affairs Officer job at Dei BioPharma Ltd | Apply Now
Are you looking for HSE jobs in Uganda 2025 today? then you might be interested in Regulatory Affairs Officer job at Dei BioPharma Ltd
About the Organisation
DEI BioPharma Drugs and Vaccines Manufacturing Plant is a pioneering pharmaceutical company dedicated to the research, development, and production of high-quality, affordable medicines and vaccines to enhance public health and disease prevention. Recognized for its commitment to pharmaceutical excellence, the company has built a strong reputation for innovation, compliance with global quality standards, and contributions to healthcare advancement in Africa and beyond.
DEI BioPharma fosters a collaborative and research-driven work culture, offering employees professional development opportunities, cutting-edge facilities, and a supportive environment that promotes scientific innovation and teamwork. The company provides diverse job opportunities in biotechnology, pharmaceutical production, quality assurance, research and development, logistics, and administration, with flexible work arrangements to support efficiency and work-life balance. Established with a vision to revolutionize Africa’s pharmaceutical industry, DEI BioPharma has rapidly grown through strategic partnerships, regulatory approvals, and continuous investment in advanced manufacturing technologies.
Its innovation-driven business model integrates state-of-the-art production processes, data-driven research methodologies, and sustainable pharmaceutical solutions to ensure accessibility, affordability, and efficacy. With a vast operational reach, the company supplies essential drugs and vaccines to local and international markets, strengthening healthcare systems and pandemic preparedness. Rooted in core values of integrity, excellence, innovation, and social responsibility, DEI BioPharma remains committed to ethical business practices and long-term health impact.
Through Corporate Social Responsibility (CSR), the company actively engages in community health programs, vaccine accessibility initiatives, pharmaceutical education, and environmental sustainability projects. For more information about products, research initiatives, and career opportunities.
Matugga, Uganda
Full Time
Job Title
Regulatory Affairs Officer job at Dei BioPharma Ltd
Dei BioPharma Ltd
Job Description
The role involves supporting regulatory strategy and lifecycle management to ensure 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.
Duties, Roles and Responsibilities
Prepare and compile registration dossiers (Modules 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.
SERVICES
COMMERCIAL
SERVICES
INDUSTRIAL
SERVICES
RESIDENTIAL
Qualifications, Education and Competencies
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related biomedical discipline.
Postgraduate certification in Regulatory Affairs is an added advantage.
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
ONLINE APPLICATION ONLY!
Interested candidates are advised that applications for this position must be submitted online. To apply please click the “Apply” button below.
