Regulatory Affairs Officer

Opening Period: 11/11/2024 – 16/11/2024

Series/Grade: L (2)

Salary: Competitive

Who May Apply: All Interested Applicants

Duration Appointment: Indefinite subject to successful completion of probationary period

The work schedule for this position is: Full Time, 45 hours per week.

Start date: Candidate must begin working within a reasonable period.

Supervisory Position: No

Duties:

• 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

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.
• Evaluations: (This may be tested)

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).

Announcement Number: DB-2024-33

How to Apply:

1. 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)
2. All Application documents should be merged as one document in PDF or .DOC/.DOCX, which should not exceed 10MB
3. Applications should be sent by email to [email protected] with the JOB TITLE IN THE SUBJECT LINE.
4. 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.

Deadline: 16th November 2024 by 5:00PM

Thank you for your application and vour interest in working at Dei Group