Regulatory Affairs Officer
2025-05-09T08:06:52+00:00
Dei BioPharma
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https://deibiopharma.com/
FULL_TIME
Matugga
Uganda
00256
Uganda
Healthcare
Healthcare
2025-05-12T17:00:00+00:00
Uganda
8
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.
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.
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related biomedical discipline. Postgraduate certification in Regulatory Affairs is an added advantage.
JOB-681db79c65d81
Vacancy title:
2 Regulatory Affairs Officer
[Type: FULL_TIME, Industry: Healthcare, Category: Healthcare]
Jobs at:
Dei BioPharma
Deadline of this Job:
Monday, May 12 2025
Duty Station:
Matugga | Uganda | Uganda
Summary
Date Posted: Friday, May 9 2025, Base Salary: Not Disclosed
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JOB DETAILS:
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.
Work Hours: 8
Experience in Months: 36
Level of Education: bachelor degree
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