Chief Regulatory Officer (Registration)-Medicines Control Authority of Zimbabwe (MCAZ)

JOB DESCRIPTION

The Medicines Control Authority of Zimbabwe (MCAZ) is inviting qualified, honest, self-motivated and experienced applicants for the post of Chief Regulatory Officer (Registration) – 1 Post.

Reporting to: The Head, Evaluations and Registration

The incumbent will be responsible for the following among other duties:

• Manage the evaluation of Human Allopathic Medicinal Products, amendments and reinstatements;
• Ensure new dossiers are correctly received, receipted, screened and relayed to the Evaluations Team;
• Ensure correct information (guidelines, fees, timelines, quotations) is given to applicants intending to submit dossiers;
• Ensure tracking of active Evaluation Team assessment time and clock stops for applicant to respond;
• Ensure presentation of information for decision making at EVR, Management and Senior Management meetings;
• Ensure timely communication of queries to applicants after completion of screen, 1st evaluation, 2nd evaluation, to applicants;
• Ensure up-to-date information for customers on the EVR homepage;
• Ensure up-to-date guidelines for EVR staff and clients;
• Ensure up-to-date forms, templates for EVR staff;
• Ensure issue of correct certificates.
• Enforce deadlines on time to respond, limit review cycles;

Requirements

• Either Bachelor of Pharmacy or Veterinary Science Degree.
• Master’s degree in Pharmaceutical Regulatory Affairs will be an added advantage.
• Experience as Senior Regulatory Officer Competency level 2 in evaluation of dossiers.
• Capacity to provide a technical advisory role to Committes through recommendations.
• Ability to conduct critical analysis and think strategically.
• Ability to induct, train, mentor and supervise administration and technical officers.
• Good time management, able to work with minimal supervision, good interpersonal skills, team player, ability to see registration process.