Drug Regulatory Affairs and Quality Manager at WTS Energy

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