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About the Organisation
Regulatory Affairs Documentation Officer job at Dei BioPharma Ltd | Apply Now
Matuga, Uganda
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.
Are you looking for HSE jobs in Uganda 2025 today? then you might be interested in Regulatory Affairs Documentation Officer job at Dei BioPharma Ltd
Full Time
Deadline:
12 May 2025
Job Title
Regulatory Affairs Documentation Officer job at Dei BioPharma Ltd
Dei BioPharma Ltd
Job Description
This position supports the Regulatory Affairs team by compiling, formatting, and archiving essential regulatory documentation related to product registration, GMP compliance, variations, and renewals. The officer will ensure the accuracy, traceability, and readiness of regulatory documents for both local and international submissions. The role involves close collaboration with internal departments and regulatory authorities to meet documentation and submission deadlines. Ideal candidates must be detail-oriented, organized, and familiar with pharmaceutical documentation systems, CTD structure, and regulatory requirements.
Duties, Roles and Responsibilities
Qualifications, Education and Competencies
See all details of the qualifications, competencies and education for this role under the "How to Apply" section below.
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How to Apply
Maintain document control systems aligned with GDP and data integrity standards (ALCOA+).
Format, compile, and archive regulatory documents for submissions and audits.
Assist in preparing CTD modules, ensuring accuracy, consistency, and correct referencing.
Track and update document revisions, approvals, and submission timelines.
Support both electronic and physical submissions to regulatory bodies.
Collect and verify technical data from internal departments for regulatory use.
Maintain regulatory trackers, indexes, and submission logs.
Ensure documents comply with guidelines from NDA Uganda, WHO PQ, ICH, etc.
Support audit readiness by organizing timely retrieval of records and controlling versions.
Provide administrative support in document-related regulatory affairs.
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Bachelor’s degree or Higher Diploma in Pharmacy, Regulatory Affairs, Quality Management, Life Sciences, or related fields.
Certification in document management or regulatory documentation is an added advantage.
At least 2–3 years of relevant experience in pharmaceutical regulatory affairs or quality documentation.
Familiarity with CTD documentation structures and regulatory submission processes.
Strong organizational and documentation skills with keen attention to detail.
Knowledge of GMP, GDP, and data integrity principles.
Proficiency in Microsoft Office and document management systems (e.g., SharePoint, TrackWise).
Ability to manage multiple document workflows and meet strict regulatory timelines.
