Job Title: Regulatory Affairs Associate
Responsible
for supporting regulatory submissions, maintaining product registration
records, preparing regulatory documents, monitoring changes in pharmaceutical
regulations, coordinating with regulatory authorities, tracking licence
renewals, and ensuring products comply with applicable regulatory requirements.
Requires a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry,
or a related field. The position is based in Nairobi and requires on-site work.
Job Summary:
Responsible
for supporting all activities related to product registration in assigned
markets. This includes preparing and submitting dossiers for new product
registrations, retentions, renewals, variations, and ensuring timely processing
of regulatory payments and documentation
Key Responsibilities:
Prepare
and compile registration dossiers in eCTD format for new registrations,
renewals, variations, and retentions in compliance with regulatory guidelines
for various export countries
Manage
timely preparation and submission of regulatory documents, including tender
documents and responses to regulatory questionnaires
Ensure
high accuracy and full compliance in all dossier submissions, with minimal to
no errors during review, signing, and approval stages
Provide
timely and accurate responses to regulatory queries following dossier
submissions to support efficient product approvals
Proactively
apply for and follow up on approvals for new product registrations, variations,
renewals, and retentions within the assigned export markets
Monitor,
process, and track all regulatory payments, ensuring timely clearance and
smooth progression of registration processes
Maintain
proper document control and filing systems to ensure all regulatory documents
are accurately recorded, securely stored, and easily retrievable
Safeguard
all regulatory records to ensure they remain complete, organized, and
audit-ready at all times
Qualifications
Minimum
of a Diploma in a science-related field;
minimum
of 1 year of experience in a similar regulatory affairs role
How to Apply
Send
application to recruitment@cosmos-pharm.com
