Regulatory Affairs Officer (Number of positions: 02)
Full time @Dei Biopharma posted 1 week ago in HealthCare Shortlist Email JobJob Detail
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Job ID 26939
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Career Level Officer
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Experience 2 Years
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Gender Both
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Industry Healthcare
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Qualifications Degree Bachelor
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Job Type Full time
Job Description
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.
Academic Qualifications:
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.
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