On behalf of our client, a growing pharmaceutical company, we are currently recruiting for Regulatory Affairs Officers for submissions. These are for permanent opportunities.
Role: • Assessment of the content and format of RA documents vs. registration requirements and guidelines. • Coordination & preparation of regulatory submissions • Negotiate and communicate effectively with regulatory authorities to obtain timely product approvals • Foster good working relationships with relevant regulatory bodies. • Ensure that timely responses to the regulatory queries raised during the evaluation process • Ensure all activities are within the framework of the Quality system, including the setting and achievement of relevant KPIs.
Requirements: • A minimum of relevant Life Science degree and/or a minimum of 1 years EU Submissions experience. • Working knowledge of EU regulatory requirements and procedures required. This includes good understanding of CMC and eCTD requirements. • Solid knowledge of IT tools specific for in RA and pharmaceutical sector (as eCTD, databases, change control management etc.) required. • Experience of working in accordance with quality standards e.g. GMP • Strong team member with the ability to identify and drive quality improvements • Good administrative/organisational ability with attention to detail is required. • Be able to work autonomously and have good problem solving skills.
For more information and to apply for this role please call Linda on 1 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1