Qualifications & Experience Required:

Proficiency in the English Language;

Be in possession of:

(a) A recognised Doctorate qualification at MQF Level 8 in Pharmacy or Chemistry, or a comparable professional science qualification plus minimum of three (3) years in regulatory science across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of human medicinal products of which at least one (1) year in the assessment of quality data for registration of medicinal products or equivalent experience in industry or academia related to the above areas.

(b) A recognised Master qualification at MQF Level 7 in Chemistry, or a comparable professional science qualification plus minimum of four (4) years in regulatory science across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control of human medicinal products of which at least two (2) years in the assessment of quality data for registration of medicinal products or equivalent experience in industry or academia related to the above areas.

Duties

The Malta Medicines Authority’s mission is to protect and enhance public health through the regulation of medicinal products and pharmaceutical activities .

The Licensing Directorate within the Malta Medicines Authority (MMA) is responsible for assessing and approving applications for marketing authorisations. The division’s activities span National and European licensing, through mutual recognition, decentralised and centralised procedures, including post-authorisation activities.

Overall purpose

The Senior Assessor (Quality) is responsible for the scientific evaluation of marketing authorisation applications for human medicinal products as part of a multi-disciplinary team. The Senior Assessor (Quality) determines the suitability for approval of the marketing authorisation of human medicinal product/s through execution of robust technical assessments of quality data of initial and variation applications for marketing authorisation. The Senior Assessor (Quality) reports to the Licensing Director and/or the designated deputy.

Functions

(a) Assist Line Management in:

Pharmaceutical, technical and scientific duties;
Compilation of publications and reports;
Mentorship and peer review; and
Managing the work related to quality assessment.

(b) Evaluate:

Quality data submitted in support of applications for marketing authorisation for human medicinal products, in accordance with established procedures;
Quality data submitted in support of applications for variations of marketing authorisations, in accordance with established procedures;
Quality data submitted in support of applications to conduct clinical trials in respect of human medicinal products (containing new chemical entities or established active ingredients);
Quality data submitted in support of scientific advice requests by pharmaceutical companies; and
Any other quality data that needs technical assessment.

Summaries and reports arising from evaluations of scientific data;
Assessment reports and authorisation documentation defining the rationale for the authorisation of a human medicinal product; and
Quality assessment policies, as required.

(d) Ensure:

Provision of technical advice;
Continuous engagement in updating and ensuring knowledge of state-of-the-art technologies and updated standards and guidelines through ongoing professional education and review of published literature, including training requirements and training sources;
Communication with applicants and other relevant persons in relation to the evaluation of quality data including liaison with fellow officers, medical, preclinical and pharmaceutical professionals;
Activities related to the assessment of authorisation and post-authorisation procedures meet requirements in terms of accuracy, completeness and timeliness;
Submission of reports as required and maintain appropriate records of meetings and activities;
Timely planning, delivery and oversight of the procedures in line with the Authority’s strategy and the resources available;
Facilitation of engagement and dialogue with Marketing Authorisation Holders, prospective pharmaceutical companies and staff of the Authority in line with Top Management direction;
Staff receives the necessary training to achieve their potential, by using delegation and empowerment to provide opportunities to develop staff and to plan for succession;
Compliance with the quality management system of the Malta Medicines Authority and regulatory requirements; and
Documentation and implementation of all policies and Standard Operating Procedures.

(e) Spearhead, coordinate and implement:

Activities of the MMA;
Assigned procedures;
Ongoing and new projects within the Licensing Directorate; and
Any other delegated projects and assignments to continuously improve processes, tools and systems for the benefit of the Malta Medicines Authority.

(f) Provide:

Relevant and consistent information and advice to Chief Executive Officer/Director/s and staff under the direction of the assigned Director, committees, government department, professional bodies and other bodies, as appropriate;
Advice to Committees established to provide guidance or overview the assessment process;
Support to staff in order to maximise their potential, in turn delivering the work in an efficient and effective manner and in line with the policies and guidelines of the Authority;
Advice to the Chief Executive Officer/Director/s as required, seeking to propose strategic solutions to the challenges in this area; and
Technical assistance and scientific output/assessment.

(g) Monitor and report performance against the key performance indicators for the area assigned.

(h) Continuously improve the performance of the organisation by:

Promoting and maintaining good professional and ethical working relationship with colleagues and stakeholders;
Promoting communication and liaison between different sections of the organisation;
Representing the Authority at meetings, including meetings of the Committees/ Working Groups, seminars, conferences and other fora, both locally as well as abroad;
Encouraging and ensuring the effectiveness and efficiency of the quality of service;
Mentoring and peer review quality assessments carried by other Assessors; and
Promoting the vision, mission, values, strategy and objectives of the Authority.

(i) Any other pharmaceutical duties and responsibilities as assigned by the Chief Executive Officer/Director/s and/or appointed substitute.

Senior Quality Assessor

Job Description