Assessor, National Licensing Maternity Contract Cover

On behalf of our client, we are currently recruiting for an Assessor, National Licensing (Acting) - Human Products Authorisation and Registration. This is a maternity contract cover role.

ROLE SUMMARY

The Assessor role will work as part of the National Licensing Section in the Human Products Authorisation and Registration department and will evaluate the quality and certain clinical aspects of new applications for human medicinal products and variations to/renewals of existing authorisations for medicinal products.

The Assessor will work closely and maintain effective working relationships with the other members of the National Licensing Section and with all members of the department to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the department are met.

KEY RESPONSIBILITIES

Technical Objectives

• Conduct scientific evaluation of quality and certain clinical data submitted in support of marketing authorisation/variation/renewal applications containing new chemical entities or established active ingredients for human medicinal products or homeopathic medicines. This includes, but is not limited to, data on the manufacture and control of drug substances and drug products e.g. formulation, process validation, analytical methods, analytical validation and stability studies.
• Detailed assessment reports summarising these evaluations may need to be prepared for submission to other EU member states.
• Conduct scientific evaluation of quality and certain clinical data submitted in support of:
  • National applications for marketing authorisations
  • Variations to existing authorised medicinal products
  • Other procedures, as required Conduct scientific evaluation of bioequivalence data in support of generic applications.
  • Analysis in the context of public health, of risk-benefit profiles in respect of applications for marketing authorisation; making recommendations and preparation and presentation of reports to the Board, Advisory Committees and Sub-Committees or the Management Committee o, and/or the CHMP or their representative working parties, regarding the suitability of human medicinal products for marketing approval.
  • Assist the National Licensing Section Manager and other managers in the section in ensuring the accuracy of relevant data inputted in the computer databases and information systems

QUALIFICATIONS AND EXPERIENCE

• A degree in pharmacy, chemistry or other relevant scientific discipline
• A minimum of 2 years relevant industrial, regulatory and/or research experience in the pharmaceutical industry, a regulatory authority or in a related field
• A proven track record of working within multidisciplinary teams
• Proven ability demonstrating excellent interpersonal, communication and presentation skills
• Direct experience working with stakeholders/customers
• Demonstrated initiative and team working capabilities
• Take ownership of tasks and ensures outcomes meet organisational and stakeholder needs.
• Use industry knowledge and innovation to support business improvements.
• Break down goals into clear, actionable steps and tracks progress regularly.
• Align individual and team priorities, adjusting plans as needed to meet objectives
• Actively look for opportunities to grow and take on new challenges.
• Expand expertise relevant to their role and future responsibilities
• A demonstrated ability to think critically and independently
• In addition, the following would be considered an advantage: A postgraduate qualification in a relevant scientific discipline or an additional years relevant experience
• Industrial / regulatory background with a breadth of experience to enable review the quality sections of a marketing authorisation applications
• Experience in interacting with the European Medicines Agency
• Experience in writing reports for external clients, organisations or the general public