Regulatory Affairs Coordinator - 1 Position at Dawa Limited

Brief Job Description:

• Ensure that the company’s products comply with the regulations in the Countries where they are distributed.
• Timely compilation and submission of registration dossiers for Kenya and other countries per required format and guidelines.
• Keep up to date with national and international legislation, guidelines, and customer practices.
• Collect, collate, and evaluate scientific data from a range of sources.
• Prepare and monitor set timelines for submissions of licenses, variations, and annual product renewals to strict deadlines.
• Verify technical product data from various departments and contracted partners as required.
• Screening of registration dossiers before submission and re-submission to VMD – Kenya.
• Responding to queries raised by various regulatory bodies after product evaluation.
• Proper record keeping of all regulatory documents assigned in a manner that they are retrievable whenever required.
• Update the product database of all Medisel Kenya limited products. Ensure the records are well kept in a traceable and retrievable manner.
• Approval of artworks, advertising copies, and veterinary detailing information to ensure regulatory compliance
• Collection of product samples from production & finished goods stores for drug registration submissions per the RA dossier preparation schedule.
• Proper record keeping of retained samples and other documents within the RA department.
• Any other assigned duties from time to time within the RA department

Key Perfomance Indicators:

• Monthly dossier compilation & submissions to various regulatory authorities both locally and internationally.
• Monthly evaluation queries responded to and submitted.
• Number of registered products both locally and internationally.

Qualifications and Experience:

• Must Have: Minimum Requirements
• To be considered, these minimum requirements must be evident on your resume.
• Education – A BSc degree, Higher diploma, or diploma in Applied and Biological sciences.
• At least 4 years of working experience in regulatory affairs both locally and internationally.
• Previous experience with VMD, NDA, ZAMRA, TMDA, DVS, or KEBS will be an added advantage

Nice to Have:

• Understanding of both legal and scientific matters.
• The ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
• Analytical and problem-solving skills.
• Written and oral communication skills.
• Attention to detail.
• Strong negotiation skills.
• IT skills, particularly in using databases and familiarity with commercial software.
• The ability to work under pressure and to strict deadlines.
• The confidence to report to management.
• Teamworking skills and the ability to lead and motivate others.
• Project-management skills.
• Integrity and a professional approach to work.