We are currently recruiting Regulatory Affairs Specialists to support a global Pharmaceutical company based in the United Kingdom, on a remote basis. As the Regulatory Affairs Specialist you will be responsible for supporting regulatory submissions in line with project timelines.
Please note the role is initially on a 12 month contract and can be worked on a remote basis.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Specialist (12 months) will be varied however the key duties and responsibilities are as follows:
1. Work alongside regional and global stakeholders including but not limited to, Global Regulatory leads, technical experts and vendors.
2. As there is more than one post, the Regulatory Affairs Specialist will support with post approval activities including variations via EU Centralised procedure, as well as Clinical Trial Applications (CTA's).
3. Act as a Regulatory Lead for assigned projects.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Pharmaceutical discipline.
2. Proven industry experience in executing Regulatory Affairs activities such as post approval variations or Clinical Trial Applications (CTA's) (Experience with both are not essential but would be a significant advantage).
3. A working knowledge and practical experience with Biologics or Oncology related submissions.
Key Words: Regulatory Affairs / RA / Regulatory Affairs Specialist / EU CP / EU Centralised Procedure / Centralised Procedure / Post approvals / Clinical Trial Applications / CTA's / Clinical Trial Amendments / EMA / Global Regulatory Affairs / Remote / Biologics / Oncology