Chief Regulatory Officer

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Chief Regulatory Officer

  • Post Date:November 3, 2021
  • Views 636
0 Applications
  • Career Level Officer
    Qualification Degree
    Experience 3-5 Years
  • Industry Health Care
Job Description

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

Reporting to: The Head, Pharmacovigilance and Clinical Trials (PVCT)

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

  • Manage and motivate team members in the execution of all aspects of the PVCT Division Annual Work Plan and projects;
  • Supervise the collection of revenue from operational activities (retention fees, clinical trials, variations and promotional material);
  • Manage and evaluate the execution of the PVCT Division skills gap analysis and training plan;
  • Performance monitoring and evaluation of PVCT Officers in line with the approved performance contracts and Division Competence matrix;
  • Supervise vigilance activities in the Division (pharmacovigilance, vaccine pharmacovigilance and haemovigilance) to reach & maintain WHO GBMT Maturity level 3;
  • Supervise Clinical Trial oversight activities, including GCP inspections to and maintain WHOGBMT maturity level 3;
  • Supervise the evaluation of safety variations, promotional material, and safety updates;
  • Supervise the automation of processes and addresses any challenges that may arise, tracking systems data cleaning, liaison with ICT support team and SLAs;
  • Manage PVCT Division publications and updates to the PVCT page of the MCAZ website;
  • Manage QMS, WHOGBT, Finance audit compliance and activities in the Division; S
  • Management PVCT budget planning, expenditure and acquittals & commitment register; 2
  • Performance, monitoring and evaluation of all PVCT processes and timelines; *

Requirements

  • Either a Bachelor of Pharmacy Honors Degree or Clinical Pharmacology or Medical Doctor or any other relevant Biomedical Sciences Degree.
  • Relevant Post Graduate Course like CT/GCP and VL.
  • At least three (3) years working experience as Senior Regulatory Officer or relevant regulatory experience.
  • Ability to critically evaluate clinical trial applications and vigilance submissions.
  • Sound knowledge of GCP principles and competence in inspections.
  • Ability to motivate team spirit, supervisory skills and interpersonal skills with internal and external customers.
  • Effective communication skills and proficiency in English.

Applicants should send their curriculum vitae, certified copies of qualifications, experience and expected salary and benefits to:

The Director-General
Medicines Control Authority of Zimbabwe
106 Baines Avenue/ Comer Third Street
P0 Box 10559
HARARE

Closing Date: 05/11/2021

Disclaimer: The Medicines Control Authority of Zimbabwe does not charge any fees to respondents to this advertisement nor to those who become successful. Applicants are advised to deal with caution if approached in regard to any offer to facilitate the applications process.

Protecting your Right to Quality Medicines and Medical Devices