Job Title: Regulatory Affairs Officer
Organization: Dei BioPharma Ltd.
Location: Uganda
Job Type: Full-time
Application Deadline: 16th November 2024 by 5:00 PM
About Dei Group
Dei Group International is a leading African conglomerate with diverse interests in agriculture, technology, medicine, and research. Dei BioPharma Ltd., a subsidiary, is a dedicated Drugs and Vaccines Manufacturing Plant committed to providing quality healthcare products in Africa.
Role Overview
The Regulatory Affairs Officer will manage regulatory submissions and ensure compliance with applicable standards for a wide range of products, including generic medicines, new chemical entities (NCEs), biological products, biosimilars, veterinary products, complementary medicines, and medical devices.
Announcement Number: DB-2024-33
Reports To: Head of Regulatory Affairs
Work Schedule: Full-time, 45 hours per week
Duration of Appointment: Indefinite, subject to successful completion of probationary period
Key Responsibilities
- Review regulatory documentation and dossiers to ensure compliance with standards and identify any deficiencies.
- Manage regulatory submissions for new product applications, variations, and appeals.
- Prepare and compile quality documents from master factory documents and raw data.
- Oversee the preparation of clinical documents, labeling, professional information, and patient information leaflets.
- Compile quality summaries, information summaries, and administrative sections of regulatory dossiers.
- Conduct GxP audits across manufacturing, packaging, distribution warehouses, and laboratories.
- Prepare licensing applications and support quality systems implementation, including SMF, QM, SOP compilation, internal audits, trend analysis, GxP training, risk management, PQRs, and change control.
Qualifications
- Education: Bachelor’s degree in Pharmacy or a related field. A Master’s degree in a relevant field is advantageous but not required.
- Experience:
- 2-3 years of experience in a regulatory affairs role within the pharmaceutical or biopharma industry.
- Familiarity with regulatory requirements for registering generic medicines, biological products, and medical devices.
Knowledge and Skills
- Knowledge of regulatory standards and guidelines, including GxP, and familiarity with local and international regulatory procedures.
- Proficiency in regulatory documentation and reporting, quality management systems, and risk management.
- Strong organizational, analytical, and problem-solving skills.
- Effective communication and presentation abilities.
- Proficiency in MS Office and standard software tools.
Language Requirement
- Advanced proficiency in English (reading, writing, and speaking).
How to Apply
Interested candidates who meet the qualifications are invited to submit their CVs, Cover Letter, and Academic documents (addressed to the Head of Human Capital) as one PDF or DOC/DOCX file (max 10MB). Applications should be sent via email to recruitment@deibiopharma.com with the Job Title in the subject line. If you do not receive feedback within 14 days after the closing date, consider your application unsuccessful.
Application Deadline: 16th November 2024 by 5:00 PM
Thank you for your interest in working with Dei BioPharma Ltd.
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