Registration And Licensing Manager at Pharmacy and Medicines Regulatory Authority

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 various positions tenable at its Head Office in Lilongwe. The following are the details of the vacant positions: –

JOB TITLE: REGISTRATION AND LICENSING MANAGER

Grade: PMRA 3
Location: Head Office
Responsible to: Director of Regulatory Services/DG

Job Purpose

To oversee and ensure effective and efficient registration and licensing of medicines, medical devices and allied substances and services in accordance with relevant laws, policies and regulations.

Key Roles and Responsibilities

1. Coordinate the development, review and implementation of ork plans, budgets regulations, guidelines and Standard Operating Procedures for registration and licensing of medicines, medical devices and allied substances and services.
2. Plan and coordinate product dossier assessment sessions and ensure generation of comprehensive reports in line with standards.
3. Manage communications with pharmaceutical manufacturers and their local agents on pre-approval queries during the registration process and post-approval variations to registered products.
4. Maintain PMRA market authorizations and product retentions, and in collaboration with Finance Department, ensure that the issued licenses are paid for.
5. Coordinate product registration and verification exercises to ascertain compliance to registration requirements.
6. Manage the registration and licensing of pharmacy education and professionals
7. Develop and oversee implementation of tools and strategies aimed at controlling product imports and exports
8. Recommend issuance of Licenses for pharmaceutical businesses, medical devices and allied substances and services
9. Ensure appropriate maintenance of register for pharmaceutical businesses
10. Review and vetting inspection reports and recommending them to the Director General for Licensing
11. Ensure that licensed pharmaceutical business premises comply with the provisions of the PMRA Act and regulations.
12. Maintain liaison and close collaboration with key stakeholder agencies involved in product quality, procurement and supply to ascertain compliance to product registration requirement
13. Prepare reports and documents for court cases in liaison with the legal counsel

Minimum Qualifications and Experience

• Bachelor’s Degree in Pharmacy
• Master’s Degree in in Pharmaceutically related field
• 5 years of relevant working experience at officer level or above.
• Registered with appropriate professional body

Person Specification

• 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 be able to lead a team of a professionals towards the achievements of goals and objectives
• 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.

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 26th July, 2025 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: [email protected]

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