Dawa Limited Regulatory Affairs Coordinator Job

Regulatory Affairs Coordinator Job, Current Legal Jobs In Kenya,

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:

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.

How To Apply

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