Job description
Roles and Responsibilities
Ensure regulatory requirements are adhered to in governance to ensure the company is regulatory compliant with all local boards and governing bodies.
Oversee compilation of drug registration dossiers for the EA region and ensuring that these are then timely followed up with relevant boards so that these products registered.
Ensure organization has all required regulatory licenses. approval and renewals
PPB (Pharmacy and Poisons Board)
Product approvals (New, Change, Retention, ii. Premises licenses (Wholesale and Retail)
Personnel licenses
Advertising approvals v. GMP approvals
Import approvals vii. Inspections
Audits
Quality Controls
Quarantine of Products
NCC – Nairobi city county government certification
Directorate of Occupational Health and safety
✓ Risk assessment Quarterly
✓ Audits Health and Safety Every Month
KEBS Products
Herbal Products
Any other regulatory body (KMF, KAPI, PSK and others)
Ensure products and artworks are complying with regulatory guidelines in timely manner
Keep Quality Head updated on regulatory matters – Weekly briefing / updates
Work under Quality Head to ensure maintenance of GDP/ Quality in the supply chain
To support business growth as processes change ensuring the quality and regulatory angle is of utmost importance
Liaise with contracted entities (Manufacturers, distributors to communicate to them our regulatory requirements and ensure they are adhered to in timely manner and escalation on matters to Operation Head
Provide weekly and monthly reports to senior management
To coordinate EA product planning and dossier review.
To manage the quality of the business ensure we attain highest standards in all processes and procedures rolled out
Standard of Operations on all Regulatory and Quality matters custodian
Ensure training and professional development of all licensed members of the team.
Ensure CPD training of all pharmacists and pharm- techs completed
To conduct audits monthly on the following:-
Supply chain quality
Rx audits
Training audits
Health/ safety audits
Be involved in risk assessment
Be involved in formulary committee
CP audits
WH audits
Product audits
To be involved in any other task the business may assign in line with these roles as it grows