Manager, Global Regulatory Submission Management

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

Full Job Description

Your new role

As a Manager within Eisai’s Global Submission Management Team, you will be responsible for leading and managing regional submission activities for a major filing (IND, NDA, sNDA, Amendments, DMFs, etc.) including the management of global submission timelines and coordination of publishing activities.

 

You will also be involved in supporting Global System development and process development on a basic level, and process redesign as well as conducting training on the submission processes for current and new team members to support new requirements for eCTD Submissions and Data Standards mandated by the regulatory agency.

 

What are we looking for?

You will have a demonstrated background in a Regulatory Affairs or Operations function with strong submission management experience.

 

Your experience should include some or all of the following:

  • Regional Regulatory Submission Knowledge: US Specific: Familiarity with FDA & ICH Regulations & guidelines, IND, NDA, sNDA, Amendments, Annual Reports, Orphan Drugs, Module 1 - Cover letter, forms, labelling & SPL, administrative information, Module 4 – STF, Module 5 –STF. Assumes overall global and regional responsibility for assigned product submissions.

  • Computer proficient in eCTD Publishing Software and document management systems

  • Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools.

 

Previous line management experience would be advantageous, but we are also open to considering individuals who can develop in this area.

 

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.