Job Description
CHIEF REGULATORY OFFICER (REGISTRATION), GRADE D2, EVALUATIONS AND REGISTRATION DIVISION

The Medicines Control Authority of Zimbabwe (MCAZ) is inviting qualified, honest, self-motivated and experienced applicants for the following post:-

Chief Regulatory Officer (Registration) – 1 Post

Duties and Responsibilities
1.0 Duties and Responsibilities

Reporting to the Head, Evaluations and Registration, the incumbent will be responsible for the following among other duties:

Manage the registration of Human Allopathic Medicinal Products, Veterinary Medicines, Complementary Medicines, amendments and reinstatements;
Preparation of Registration Unit Operational Plan for review and approval by Head Evaluations and Registration;
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;
Liaise with the CRO-Evaluations so that dossiers that passed screening are handed over to the Evaluations Team with an agreed timeline for evaluation;
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;
Liaise with the inspectorate to confirm GMP status of manufacturers;
Ensure satisfactory resolution of all QMS internal and external audit observations;
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.


Qualifications and Experience
Requirements

Either Bachelor of Pharmacy Degree or Veterinary Science Degree or related field.
Master’s degree in Pharmaceutical Regulatory Affairs will be an added advantage.
Experience as Senior Regulatory Officer coupled with competency level 2/3 in evaluation of dossiers.
Capacity to provide technical advisory role to Committees 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.