Contractor - CMC Regulatory Affairs

Salary & Benefits
Competitive
Employment Type
Full Time, Contract - 6 Months
Department
CMC Regulatory
Report to Position
Director, CMC Regulatory
Location
EMEA Knowledge Centre, Hatfield, Hertfordshire
Business Area
Application Deadline
21 December 2018

Full Job Description

Your new role

As a Contractor within Eisai’s CMC Regulatory team, you will be involved in providing CMC support and guidance to the EMEA region, including:

  • Leading the preparation of submission documents (IMPD-Q, Module 3 for MAA or license variations) and provides response to questions from health authorities in a timely manner.

  • Ensure submissions meet standards of health agencies.

  • Providing industry & legislative updates in relation to CMC to mitigate future risks for Eisai.

 

The CMC Regulatory Team provide a broad range of support to the business, so the Contractor will also support other areas as required to meet business needs.

 

What are we looking for?

You will have a qualification / background in a scientific discipline (e.g. Chemistry, Pharmacy etc.) or equivalent.

 

You should have demonstrated experience in a CMC Regulatory role, with previous experience in R&D, manufacturing or clinical marketed products an advantage, but not essential. You should then have experience of some or all of the following:

  • An accomplished 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 and/or analytical testing.

  • Experience dealing with agencies and preparation of briefing documents 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.