Chief Medicines Registration Officer


Jobs in Lilongwe Malawi Pharmacy and Medicines Regulatory Authority Jobs in Lilongwe Chief Medicines Registration Officer Jobs in Lilongwe at Pharmacy and Medicines Regulatory Authority Chief Medicines Registration Officer Employment opportunities Pharmacy and Medicines Regulatory Authority


Closes*> May 14, 2021

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Pharmacy and Medicines Regulatory Authority

The Pharmacy and Medicines Regulatory Authority (PMRA) invites applications
from suitably qualified, highly motivated and well experienced persons of
Malawi origin to fill management positions tenable at the Pharmacy and
Medicines Regulatory Authority Head Office in Lilongwe.

#### THE ORGANISATION

The Pharmacy and Medicines Regulatory Authority is a body corporate created by
an Act of Parliament Number 9 of 2019 with the mandate to regulate medicines
and allied substances, pharmaceutical businesses and pharmacy personnel and
pharmacy training institutions in Malawi.

#### DETAILS OF THE POSITIONS

The details of the vacant positions are as follows

CHIEF MEDICINES REGISTRATION OFFICER – GRADE 3

Reporting to the Director General, the Chief Medicines Registration Officer
will be responsible for overall
management of pharmaceutical product quality assessment and safety
surveillance activities. He/She will also oversee the training and licensing
of pharmacy personnel to ensure delivery of quality
pharmaceutical care. The prospective officer will head the Registration
Department.

DUTIES AND RESPONSIBILITIES

i. Lead review process of pharmaceutical product dossiers to ensure an
effective and efficient drug
registration system and summarize findings for technical committee’s
consideration;

ii. Co-ordinate Clinical Trial Protocol Review Process and summarize
observations for the technical
committee responsible for regulation of Clinical Trials;

iii. Implement a GCP inspections program for registered clinical trials to
ensure protection of study subjects and generation of quality and credible
results;

iv. Prepare short and long term strategies required for implementation of a
functioning Pharmacovigilance system required to ascertain safety of
pharmaceutical products on the market;

v. Facilitate development of competency standards for pharmaceutical training
and ensure regulatory
compliance to pharmaceutical practice standards;

vi. Ensure Liaison and close collaboration with key stakeholder agencies
involved in enhancement of quality, safety, rational use, access, procurement,
and supply of pharmaceutical products;

vii. Perform any other duties as may be required by the Director General.

QUALIFICATIONS AND EXPERIENCE

> Bachelor of Pharmacy Degree from a recognized University
> Must be a registered Pharmacist with the PMRA
> High degree of integrity and good conduct
> Post-graduate qualification in Pharmaceutical Quality or Safety related course would be an
advantage.

> At least five years’ experience in a pharmaceutical regulation related field.

PERSONAL ATTRIBUTES

> Must be a self-starter and innovative
> Must have the technical knowledge and understanding of the pharmaceutical regulatory
environment

> Possess excellent communications (both oral and written) and interpersonal skills
> Must have the ability to develop departmental plans and implement strategy for the Authority
> Must be able to lead a team of professionals towards the achievement of goals and objectives of the Authority and be part of the management team.
> Must be of high integrity and proven track record of achievement of results
> Must be fully conversant with the provisions of the PMRA Act number 9 of 2019.
> Must be fully computer literate in Microsoft packages.
> No criminal record.

#### METHOD OF APPLICATION

Interested individuals should submit their application with (i) with an up-to-
date curriculum vitae(CV) with three traceable referees. At least one of whom
should have been a first or second level supervisor of the applicant within
the last 5 years; and (ii)certified true copies of their Academic and
Professional Qualifications. The application should be sent to the address
below –

The Acting Director General
Pharmacy and Medicines Regulatory Authority.
Off Paul Kagame/Chilambula Road
PO. Box 30241
Capital City
LILONGWE 3

Or Electronic Submission

Electronic submission of the application and accompanying materials to be
mailed as attachments in PDF or MS Word format to [ dg@pmra.mw
](mailtodg@pmra.mw) . The subject line of the application should indicate the
Position(s) applied for.

Applications must reach the Director General of PMRA not later than Friday,
14th May 2021.

Only shortlisted candidates will be acknowledged.

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Jobs in Lilongwe Malawi Pharmacy and Medicines Regulatory Authority Jobs in Lilongwe Chief Medicines Registration Officer Jobs in Lilongwe at Pharmacy and Medicines Regulatory Authority Chief Medicines Registration Officer Employment opportunities Pharmacy and Medicines Regulatory Authority


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