European Regulatory Affairs Manager – Oncology

Location: Crawley  |  Hampshire  |  England
Sector: Life Sciences
Consultant: Matthew Pitcher
Job Reference: HQ00000079
Salary: £50000 - £70000
Job Status: Permanent / Full Time

European Regulatory Affairs Manager – Oncology/Immunology

My client is seeking an experienced regulatory affairs manager with industry experience to assist with building our regulatory affairs department and be involved in the development of new drugs and medical devices being evaluated for the diagnosis and treatment of cancer.

Responsibilities:

  • Responsible for managing and coordinating regulatory activities focused on European projects
    • Guarantee that all regulatory submissions are successfully assembled according to the highest regulatory standards
    • Strategic cross-functional interaction with a variety of departments to provide EU regulatory solutions to problems including the management of timelines to complete regulatory submissions on time
    • Responsible for providing assistance to perform effectively the planning, critical reviews and scientific writing of a number of regulatory activities such as IMPDs, DSURs, study protocols, IBs and patient information sheets in order to successfully obtain the regulatory approval
    • Validate and provide input into our clients’ regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where required
    • Responsible for tracking and managing accordingly to current and new regulatory standards and requirements relevant to regulatory aspects
  • Line and day to day management of regulatory affairs team. 
  • Adhere to the Company’s quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in the job description

Requirements:

  • Minimum a MSc degree in Life Sciences – Ph.D. is preferred
    • Project Management experience is essential
    • Substantial direct EU regulatory experience with over 8 years of experience in the pharmaceutical industry, preferably in oncology or immunology
    • Direct experience of working with EU National Health Authorities and EMA is preferred