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.
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