Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

Advanced university degree in medicine, biology, pharmacy or microbiology.  

Desirable:

A postgraduate degree in biostatistics. 

Experience

Essential:

Over ten years’ experience in the pharmaceutical field.

Extensive experience in the area of CMC of vaccines including the understanding of Quality Systems.

Experience in the regulation, manufacturing and control of vaccines, and ability to work in a complex international environment.

Experience in monitoring of regulations and regulatory systems of NRAs, including lot release, manufacture and laboratory good practices, laboratory access, post-marketing surveillance (quality aspects) and other activities like writing regulatory procedures. 

Desirable: 

Participation in WHO evaluations of NRA and vaccine manufacturers as well as in other WHO activities.

Skills: 

Essential:

Expert must have technical skills and knowledge on the development, strengthening and monitoring of regulatory systems for vaccines, drugs, biologicals, and medical devices.  

Desirable:

Familiarity with WHO prequalification procedure, with WHO activities in strengthening the capacity to regulate clinical trials, vaccines as a biological medical product and /or with the NRA assessment procedure.

Languages required:

Essential:  

Expert knowledge of English.