3 Regulatory Affairs Documentation Officer
2025-05-09T08:24:03+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 Documentation Officer is responsible for the organization, control, formatting, review, and archival of regulatory documents related to product registration, variations, renewals, and GMP compliance. The role ensures that all documents meet internal and external submission requirements, comply with current Good Documentation Practices (GDP), and are prepared in accordance with regulatory guidelines such as the Common Technical Document (CTD). The Documentation Officer will support Regulatory Affairs Officers in dossier compilation and lifecycle management activities and maintain accurate, traceable records for all regulatory submissions. The ideal candidate should have a strong understanding of pharmaceutical documentation systems, attention to detail, and the ability to manage large volumes of data under regulatory scrutiny.
Key Duties and Responsibilities:
- Maintain and update regulatory document control systems in accordance with GDP and data integrity principles.
- Format, compile and archive regulatory documents required for product registration, variations, and renewals.
- Assist in the preparation of CTD modules by ensuring proper document alignment, pagination and referencing.
- Track document revisions, approvals, and submission timelines to ensure regulatory readiness.
- Support electronic and paper-based submissions to local and international regulatory authorities.
- Coordinate the collection and verification of technical data from cross-functional departments for submission.
- Prepare and maintain regulatory trackers, logs, and indexes to monitor document status and submission history.
- Ensure document compliance with applicable regulatory guidelines (e.g., NDA Uganda, WHO PQ, ICH).
- Facilitate internal audits and regulatory inspections by ensuring timely document retrieval and version control.
- Provide administrative support to the Regulatory Affairs team in document-related matters.
Academic Qualifications:
Bachelor’s degree or Higher Diploma in Pharmacy, Regulatory Affairs, Quality Management, Life Sciences, or a related field. Certification in document management systems or regulatory documentation is an added advantage.
Experience and Competencies:
- Minimum of 2–3 years’ experience in regulatory affairs or quality documentation in a pharmaceutical manufacturing setting.
- Familiarity with CTD structure and documentation requirements for regulatory submissions.
- Strong organizational and document control skills with attention to detail.
- Knowledge of GMP, GDP, and data integrity (ALCOA+) principles.
- Proficiency in Microsoft Office and document management systems (e.g., SharePoint, TrackWise).
- Ability to manage multiple document workflows under strict timelines and regulatory expectations.
Maintain and update regulatory document control systems in accordance with GDP and data integrity principles. Format, compile and archive regulatory documents required for product registration, variations, and renewals. Assist in the preparation of CTD modules by ensuring proper document alignment, pagination and referencing. Track document revisions, approvals, and submission timelines to ensure regulatory readiness. Support electronic and paper-based submissions to local and international regulatory authorities. Coordinate the collection and verification of technical data from cross-functional departments for submission. Prepare and maintain regulatory trackers, logs, and indexes to monitor document status and submission history. Ensure document compliance with applicable regulatory guidelines (e.g., NDA Uganda, WHO PQ, ICH). Facilitate internal audits and regulatory inspections by ensuring timely document retrieval and version control. Provide administrative support to the Regulatory Affairs team in document-related matters
Bachelor’s degree or Higher Diploma in Pharmacy, Regulatory Affairs, Quality Management, Life Sciences, or a related field. Certification in document management systems or regulatory documentation is an added advantage. Experience and Competencies: Minimum of 2–3 years’ experience in regulatory affairs or quality documentation in a pharmaceutical manufacturing setting. Familiarity with CTD structure and documentation requirements for regulatory submissions. Strong organizational and document control skills with attention to detail. Knowledge of GMP, GDP, and data integrity (ALCOA+) principles. Proficiency in Microsoft Office and document management systems (e.g., SharePoint, TrackWise). Ability to manage multiple document workflows under strict timelines and regulatory expectations.
JOB-681dbba36a250
Vacancy title:
3 Regulatory Affairs Documentation 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 Documentation Officer is responsible for the organization, control, formatting, review, and archival of regulatory documents related to product registration, variations, renewals, and GMP compliance. The role ensures that all documents meet internal and external submission requirements, comply with current Good Documentation Practices (GDP), and are prepared in accordance with regulatory guidelines such as the Common Technical Document (CTD). The Documentation Officer will support Regulatory Affairs Officers in dossier compilation and lifecycle management activities and maintain accurate, traceable records for all regulatory submissions. The ideal candidate should have a strong understanding of pharmaceutical documentation systems, attention to detail, and the ability to manage large volumes of data under regulatory scrutiny.
Key Duties and Responsibilities:
- Maintain and update regulatory document control systems in accordance with GDP and data integrity principles.
- Format, compile and archive regulatory documents required for product registration, variations, and renewals.
- Assist in the preparation of CTD modules by ensuring proper document alignment, pagination and referencing.
- Track document revisions, approvals, and submission timelines to ensure regulatory readiness.
- Support electronic and paper-based submissions to local and international regulatory authorities.
- Coordinate the collection and verification of technical data from cross-functional departments for submission.
- Prepare and maintain regulatory trackers, logs, and indexes to monitor document status and submission history.
- Ensure document compliance with applicable regulatory guidelines (e.g., NDA Uganda, WHO PQ, ICH).
- Facilitate internal audits and regulatory inspections by ensuring timely document retrieval and version control.
- Provide administrative support to the Regulatory Affairs team in document-related matters.
Academic Qualifications:
Bachelor’s degree or Higher Diploma in Pharmacy, Regulatory Affairs, Quality Management, Life Sciences, or a related field. Certification in document management systems or regulatory documentation is an added advantage.
Experience and Competencies:
- Minimum of 2–3 years’ experience in regulatory affairs or quality documentation in a pharmaceutical manufacturing setting.
- Familiarity with CTD structure and documentation requirements for regulatory submissions.
- Strong organizational and document control skills with attention to detail.
- Knowledge of GMP, GDP, and data integrity (ALCOA+) principles.
- Proficiency in Microsoft Office and document management systems (e.g., SharePoint, TrackWise).
- Ability to manage multiple document workflows under strict timelines and regulatory expectations.
Work Hours: 8
Experience in Months: 24
Level of Education: bachelor degree
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