Senior Manager or Associate Director, CMC Regulatory - Small Molecule & Biologics

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
07 December 2018

Full Job Description

Your new role

As a Senior Manager or Associate Director within Eisai’s CMC Regulatory Team, you will be responsible for driving forward CMC based activities in relation to small molecules and biologic products (primarily monoclonal antibodies [mAbs]) in development from a global perspective and strengthen the science and scientific arguments made in the Quality section of all submissions (IMPDs/INDs, Briefing documents for scientific advice, BLAs/MAAs, variations etc.) made by Eisai.  .

 

This will include leading the preparation of submission documents and provide response to questions from health authorities in a timely manner; researching into and providing guidance around potential small molecule & biologics CMC changes & risks as well as liaising with stakeholders across the business, but in particular regulatory & clinical development, 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 supporting new chemical entities and biologic products. 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 the development and/or manufacture of small molecules and biologics (mAbs) compounds.
  • Experience of the development and manufacture of multiple dosage forms including process validation.
  • A good working knowledge of the analytical aspects relevant to small molecules and biologics (mAbs) including specification setting. 
  • Experience in making regulatory submissions and dealing with regulatory agencies, preparation of briefing documents and holding agency meetings relating to CMC/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.