Pharmaceutical Assessor

CPL

Dublin City Centre

On behalf of our client we are accepting applications for a Pharmaceutical Assessor . In this role, you will work as part of the Pharmaceutical Assessment section in the companys Human Products Authorisation and Registration (HPAR) department. You will assist with the evaluation of the quality aspects of new applications for human medicinal products, along with variations to/renewal of existing authorisations for pharmaceutical products containing new chemical entities or established active ingredients. Responsibilities include but are not limited to: Conducting scientific evaluation of quality data submitted in support of applications for marketing authorisation containing new chemical entities or established active ingredients. Conducting scientific evaluation of quality data submitted in support of National applications for marketing authorisations, Centralised applications to the EMA and EU applications. Assisting and working with the Pharmaceutical Assessment Manager to Meet the goals and objectives of the section and upkeep and further develop the Quality Management System (QMS) procedures for the section. Participating in the performance development programme within the Pharmaceutical Assessment section to maximise efficiency gains for the Human Medicines Department. Conducting technical liaison with applicants, regulatory authorities, healthcare professionals and other relevant stakeholder. To ensure the provision of adequate technical, non-technical and continuous professional development for colleagues in the section and within the department. Desirable Qualifications and Experience: A degree in pharmacy, chemistry or other relevant scientific discipline. A minimum of 3 years relevant industrial, regulatory and/or research experience in the pharmaceutical industry, a regulatory authority or in a related field. A postgraduate qualification in a relevant scientific discipline or an additional three years relevant experience. Direct experience working with stakeholders/customers. Industrial / regulatory background and the necessary breadth of experience to review the quality sections of a marketing authorisation application. Experience in dealing with EMA. For further details contact Nicola at +353 1 2784671 or email your CV to ndunphy@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. This job originally appeared on RecruitIreland.com.

1871 days ago