Regulatory Affairs Manager - EU submissions

Key People Limited
40,000 - 60,000
07 Oct 2017
05 Nov 2017
Contract Type
Full Time
My client, a top 15 pharmaceutical company based in Essex is currently searching for a Regulatory Affairs Manager to join their team and oversee a regulatory officer. If you have a strong background in European Regulatory Affairs and enjoy working in a varied and fast-paced environment, this role could be a great fit for you.The focus of the role will be on the submission of new generic Marketing Authorisation Applications for a wide variety of products and dosage forms for Retail use registered via the Decentralised or Mutual Recognition Procedures.You will primarily work with third party partners, specifically on European projects and be responsible for reviewing the technical content of third party dossiers against EU regulatory requirements for generic products. In addition you will prepare and submit high quality regulatory dossiers and post marketing documentation. Skills & ExperienceTo be considered for this role you will have the below skills and experience:? Degree (or equivalent) in a Life Sciences or Pharmacy related subject? Substantial industrial experience within Regulatory Affairs including practical experience of European submission procedures? A good understanding of European regulatory requirements and guidelines for generic products.? Previous CMC experience (or a demonstrated technical aptitude) and familiarity with the scientific content of the dossier? Previous supervisory or mentoring experience would be an advantageMain Responsibilities? Review the technical content of third party dossiers as part of the in-licensing decision making process? Work closely with third party partners in order to prepare and submit high quality regulatory dossiers including Marketing Authorisation Applications, response to Health Authority questions and critical pre-launch post-approval variations? Be able to understand complex issues and clearly communicate issues to customer base ? Represent team during strategic and technical discussions, including participating in project teams? Enjoy the challenge of working under pressure whilst consistently ensuring that internal and external deadlines are met? Line management of a Regulatory Affairs AssociateFor further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email