Regulatory Affairs Manager - Oncology

Salary & Benefits
Competitive
Employment Type
Full Time, Permanent
Department
Oncology Regulatory Affairs
Report to Position
Director, Global Regulatory Strategy, Oncology
Location
EMEA Knowledge Centre, Hatfield, Hertfordshire
Business Area
Application Deadline
28 June 2019

Full Job Description

Your new role

As a Manager within Eisai’s EMEA Oncology Regulatory Affairs Team, you will be responsible for providing EU regulatory support to Eisai’s Oncology product portfolio across the full lifecycle from clinical trials through to maximising product lifecycle management & licence maintenance for current marketed products.

 

This will include:

  • Ensuring the timely submission of all clinical trial applications for New Active Substances (NASs);

  • Contributing to clinical development plans & global regulatory strategic plans;

  • Providing advice on EU regulatory clinical trial and marketing authorisation requirements to the International Project Teams (IPTs) or Regulatory Sub-team;

  • Supporting MAA submissions for compounds assigned.

 

What are we looking for?

You will have demonstrated experience gained within a Regulatory Affairs role in a Pharmaceutical industry setting. This will include:

  • Familiarity with EU clinical trial regulations and procedures, including VHP.
  • Experience in liaising with regulatory authorities (both in writing and verbally).
  • Life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions, negotiating labelling with regulatory authorities.

 

Specific experience in Oncology would be advantageous but is not essential.

 

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package.

 

You will also be based from our excellent Knowledge Centre facility, which provides a great, collaborative working environment coupled with a campus feel including facilities such as restaurant, coffee shop and dry cleaning services.

 

What you need to do next

If you are interested in this position, please click the ‘click here to apply’ at the bottom or top of this advert. On submitting an application please include a copy of your CV for review. On applying, you will be asked for your current salary / package details, your notice period and your current location - applications without this information may not be considered.

 

If you have any questions, please contact us on recruitment@eisai.net.

 

We aim to respond to all successful applications as soon as possible. However please note unfortunately due to the volume of applications received we are unable to respond to unsuccessful applications.