Regulatory Affairs Coordinator
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
