Manager or Senior Manager, CMC Regulatory

Salary & Benefits
Competitive
Employment Type
Full Time, Permanent
Department
CMC Regulatory
Report to Position
Director, CMC Regulatory
Location
EMEA Knowledge Centre, Hatfield, Hertfordshire
Business Area
Application Deadline
23 November 2018

Full Job Description

Your new role

As a Manager or Senior Manager within Eisai’s CMC Regulatory Team, you will be responsible for driving forward CMC based activities within regulatory and wider Eisai operations.

 

This will include leading the preparation of submission documents (IMPD-Q, Module 3 for MAA or license variations) and provide response to questions from health authorities in a timely manner; researching into and providing guidance around potential CMC changes & risks as well as liaising with stakeholders across the business to provide support where required.

 

What are we looking for?

You will have a demonstrated background in a CMC Regulatory function or wider related function. Previous experience in other relevant areas such as R&D, Manufacturing, clinical marketed products etc. would be advantageous.

 

You should also have some or all of the following:

  • Working knowledge of both the formulation and analytical aspects of R&D.

  • A strong working knowledge of the application of the principles of chemistry to drug synthesis.
  • Experience of the development of solid, liquid and parenteral dosage forms, including process validation.
  • Experience dealing with agencies, preparation of briefing documents and holding agency meetings relating to Quality issues.

 

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.