Banner Image

Daily new jobs

  • Location

    Leiden, Netherlands

  • Job title:

    Regulatory Affairs Scientist

  • Sector:

    Biotechnology

  • Job ref:

    43808

  • Startdate:

    2020-05-01

The company
The mission of this company is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. This company is bringing innovative science, together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results new medicines.

For more than 25 years this company is a leader in the field of biomedicines.

Role description
As a Regulatory Affairs Scientist you will be involved in development, post-approval and Life Cycle Management. Participate in global Regulatory team meetings and advise the Regulatory team on applicable regulatory requirements. 

Responsibilities

  • Input in development, post-approval and Life Cycle Management
  • Liaison with Regulatory Agencies and Local Operating Companies
  • Act as a back-up contact with Regulatory Agencies as needed
  • Input in document and process development
  • Support of Marketing Authorization Applications (MAA) in EMEA region
  • Review protocols and ensure alignment with Regulatory Requirements (Clinical Trial Applications)

Requirements

  • Master's Degree in Life Sciences (Pharmacy, Biology or Veterinary)
  • Minimal 2 years' of experience in Regulatory Affairs
  • Good knowledge of the Regulatory environment, guidelines and practices of EMEA regions
  • Project Management skills
  • Good organizational skills 

Apply via the button below to contact me!

Contact