MEDICINES AND LICENSING OFFICER
Full Time
November 27, 2024
Lilongwe, Malawi
December 5, 2024

Company: Pharmacy and Medicines Regulatory Authority (PMRA)

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Overview

Pharmacy and Medicines Regulatory Authority (PMRA) is a Statutory body created by an Act of Parliament No. 9 of 2019 with the mandate to regulate medicines and allied substances, pharmacy businesses and the practice of pharmacy in Malawi.

In a bid to strengthen human resource capacity in delivering this mandate, the Authority is inviting applications from suitably qualified, highly motivated and experienced persons of Malawi origin to fill positions tenable at its Head Office in Lilongwe. The following are the details of the vacant positions: โ€“

Position: Medicines and Licensing Officer (2)
Grade: PMRA 5
Reporting to : Senior Medicines and Licensing Officer
Location : Head Office
Directorate: Regulatory Services
Reporting to: Senior Regulatory and Licensing Officer

Job Purpose

To oversee and ensure effective and efficient regulatory and licensing of medicines and other pharmaceutical products and substances prior to registration in accordance with relevant laws, policies and regulations.

Key Duties and Responsibilities

  1. Ensure that dossiers are submitted and processed as per standard operating procedures
  2. Review medicine registration documentation submitted by manufacturers.
  3. Attend and respond to customer enquiries or queries related to product registration or post-approval amendments
  4. Coordinate product registration, and verification exercises to ascertain compliance to registration requirements.
  5. Plan, coordinate, implement and monitor inspection of pharmaceutical establishments locally and internationally for purposes of licensing and monitoring compliance to regulations
  6. Maintain register for pharmaceutical businesses
  7. Assist in reviewing and vetting inspection reports for Licensing Maintain liaison and close collaboration with key stakeholder agencies involved in product quality, procurement and supply to ascertain compliance to product registration requirement
  8. Prepare and update register of Medicines, Cosmetics, Medical Devices, Traditional Medicines and Food/Feed Supplements.
  9. Process applications and manage queries related to assessment and registration of products.
  10. Prepare reports and documents for court cases in liaison with the legal counsel

Minimum Qualifications and Experience

  • Bachelorโ€™s Degree in Pharmacy
  • At least 3 years of relevant working experience.
  • Registered with appropriate professional body
  • Must be a self-starter and innovative
  • Must have technical knowledge and understanding of the medicine regulatory environment
  • Must possess excellent interpersonal communication skills
  • Must have the ability to develop departmental plans and implement strategy for the Authority.
  • Must be able to lead a team of a professionals towards the achievements of goals and objectives of the Authority
  • Must be of high integrity and possess proven track record of achievements of results and be part of the management team.
  • Must be fully conversant with the provisions of the PMRA Act.
  • Must be fully computer literate in Microsoft packages;

Method of Application

Interested candidates should submit a written and signed application letter, certified copies of academic and professional qualifications and Curriculum Vitae, with three(3) traceable referees by 5th December, 2024 to:

The Director General
Pharmacy and Medicines Regulatory Authority
Off Paul Kagame Road
Next to MRA Domestic Taxes Office
P.O. Box 30241
Capital City
LILONGWE 3.
Email: recruitment@pmra.mw

PMRA is an equal opportunities employer: Only short-listed applicants will be acknowledged.