Job Title: Â Regulatory Affairs Officer (Fresher Jobs) Â
Organisation: Dei BioPharma Ltd
Duty Station: Matugga, Wakiso, Uganda
About the Company:
Dei BioPharma Ltd is a biotech and pharmaceutical research firm duly incorporated in Uganda, specializing in the development and manufacture of innovative medicines and vaccines. Our state-of-the-art manufacturing facility, situated in Matugga, Wakiso district, Uganda, shall produce high-quality medicines across a wide range of therapeutic areas.
Job Summary: Dei BioPharma Ltd., a Drugs and Vaccines Manufacturing Plant, is seeking eligible and qualified applicants for the position of Regulatory Affairs Officer.
The successful candidate will be responsible for managing regulatory submissions and ensuring compliance with applicable standards for the introduction of generic medicines, new chemical entities (NCEs), biological and biosimilar products, veterinary products, complementary medicines, and medical devices.
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Key Duties and Responsibilities:
- Review documentation and dossiers to identify deficiencies and ensure regulatory compliance.
- Handle regulatory submissions for new product applications, variations, and appeals.
- Prepare and compile quality documents from master factory documents/raw data.
- Oversee preparation of clinical documents, labeling, professional information, and patient information leaflets.
- Compile quality summaries, information summaries, and administrative dossier sections.
- Conduct GxP audits for manufacturing, packaging, distribution warehouses, and laboratories.
- Prepare licensing applications and provide support in implementing quality systems including SMF, QM and SOP compilation; internal audits, trend analysis, GxP training, risk management, PQRs, and change control.
Qualifications, Skills and Experience:
Education:
- Bachelor’s degree in Pharmacy or related field.
- An advanced Degree (master’s) in a relevant field is an advantage 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 the registration of generic medicines, biologicals, and medical devices.
Job knowledge:
- Knowledge of regulatory standards and guidelines, including those for GxP, as well as proficiency in local and international regulatory procedures and compliance requirements.
- LANGUAGE: English level IV (Advanced knowledge)
- Reading/Writing/Speaking is required.
Skills and abilities:
- Strong organizational skills with attention to detail.
- Proficiency in regulatory documentation and reporting.
- Analytical and problem-solving skills.
- Knowledge of quality management systems and risk management.
- Effective communication and presentation skills.
- Proficiency in standard software (e.g., MS Office).
How to Apply:
All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Head Human Capital)
All Application documents should be merged as one document in PDF or .DOC / .DOCX, which should not exceed 10MB
Applications should be sent by email to recruitment
deibiopharma.com with the
JOB TITLE IN THE SUBJECT LINE.
Deadline: 16th November 2024 by 5:00PM
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NB: Should you not hear from us within fourteen (14) days from the closing date of this advertisement, you may consider your application to be unsuccessful.
For more of the latest jobs, please visit https://www.ugashare.com or find us on our facebook page https://www.facebook.com/Ugashare
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