CHIEF REGULATORY OFFICER (REGISTRATION), GRADE D2, EVALUATIONSAND REGISTRATION DIVISION – Medicines Control Authority of Zimbabwe 48 views

JOB VACANCY

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

⦁ Duties and Responsibilities
Reporting to the Head, Evaluationsand Registration,the incumbent will be responsible for the following among other duties:
⦁ Manage the registration of Human Allopathic Medicinal Prod ucts, Veterinary Medicines, Complementary Medicines, amendments and reinstatements;
⦁ Preparation of Registration Unit Operational Plan for review and approval by Head Evaluationsand Registration;
⦁ Ensure new dossiers are correctly received, receipted, screened and relayed to the Evaluations Team;
⦁ Ensure correct information (guidelines, fees, timelines, quotations) isgivento applicants intendingto submit dossiers;
⦁ Liaise with the CRO-Evaluations so that dossiers that passed screen ing 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 applicantto 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 I nspectorate to confirm GMP status of manufacturers;
⦁ Ensure satisfactory resolution of all QMS internal and external audit observations;
⦁ Ensure up-to-date information forcustomers on the EVR homepage;
⦁ Ensure up-to-date guidelines for EVRstaff 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.

2.0 Requirements
⦁ Either Bachelor of Pharmacy Degree or Veterinary Science Degree or related field.
⦁ Masters 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.
⦁ Abilityto conduct critical analysis and think strategically.
⦁ Abilityto 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.

The MCAZ Is an equal opportunity employer. Female candidates are encouraged to apply.