Job Summary

Reporting to the Regulatory Manager, the position is responsible for ensuring efficient management of Dossiers and follow up with the national regulatory authorities.

  • Minimum Qualification: Bachelor
  • Experience Level: Entry level
  • Experience Length: 2 years

Job Description

REPORTING TO: REGULATORY AFFAIRS MANAGER


Background.

A leading Pharmaceutical manufacturing company seeks to recruit a highly motivated professional to fill the position of a Regulatory Affairs Assistant. The company fosters to provide quality products efficiently and effectively. We are committed to providing a safe and dynamic work environment. We encourage our team to be self-starters and allow them to demonstrate their abilities.


Duties and Responsibilities.

  1. Timely compilation of registration dossier for Kenya and other countries as per required format and guidelines.
  2. Liaising with respective departments to get relevant data for dossier preparation from QC/QA/Production departments and contract(external)manufacturers.
  3. Maintaining progress reports for all RA operations for presentation at meetings and to the management.
  4. Screening/Review of registration dossiers from contract manufacturers before submission to PPB – Kenya.
  5. Information search from available sources for drug registration.
  6. Assist in responding to queries raised by various regulatory bodies/customers/NGO on drug product registration within stipulated timelines.
  7. Assist in responding to queries raised by various regulatory bodies/customers/NGO on drug product registration within stipulated timelines.
  8. Keeping track with the ever-changing legislation in all countries where the company wants to market their products
  9. Proper record keeping of all Regulatory documents assigned in a manner that they are retrievable whenever required.
  10. To ensure the documents required as pre - regulatory guidelines within the target timelines.
  11. Submission/follow up on pre-registration analysis of samples submitted to WHO-prequalified laboratories.
  12. Follow up on trade mark registration as required by sales marketing department.
  13. Follow up on product registration and variation application status with pharmacy and poisons board.
  14. Monitor supplier performance to assess ability to meet quality and delivery requirements.
  15. Any other duty as may be assigned by person in authority.


POSITION SPECIFICATION

  • Bachelor’s degree in Pharmacy
  • Professional Qualification: Diploma in Pharmacy.
  • Registered Member of a pharmacy and poisons board.
  • Minimum of 2 years of experience in similar position. 

 

How to Apply

Applications including an application letter and curriculum vitae should be submitted.

Only shortlisted candidates will be contacted. 

Canvassing will lead to automatic disqualification. We are an equal opportunity employer.

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