Associate Director/Senior Manager Cmc

Your new role

As an Associate Director/Senior Manager CMC Regulatory, you will be required to,

• Provide CMC-Regulatory support on specific projects/queries relating to CMC for development projects and approved products from a global perspective and strengthen the science and scientific arguments made in the Quality section of all submissions (for example, IMPDs/INDs, briefing documents for scientific advice, MAAs/NDAs, variations and renewal activities for approved products) made by Eisai.
• Provide CMC expertise at Health Authority meetings.
• Collaborate with IPT and CMC teams included EDCS (manufacturing)/QA etc. (commercial team members) to advance development projects/approved products toward submission/approval.
• Provide CMC input into Regulatory Submissions (original, variations and renewal etc.) and Clinical Development Plans, as well as pro-actively inform stakeholders of draft and new regulations/guidelines which could impact on current development projects/approved products.

What are we looking for?

You will have,

• Extensive experience in the pharmaceutical industries with proven experience in CMC regulatory supporting new chemical entities and small molecule products.
• In-depth knowledge of Regulatory Affairs and Quality Assurance.
• Experience in making regulatory submissions and dealing with regulatory agencies, creation/authoring of CTD dossiers/briefing documents etc., as well as holding agency meetings relating to CMC/Quality issues.
• Experience of liaising between CMC and Clinical as well as representative of the company in contacts with Health Authorities (HAs).
• Thorough understanding of regulations, guidelines, and Heath Authority Directives.
• Experience of preparing CMC dossiers for IND, IMPD, MAA, NDA, BLA, sNDA, IMPD etc., and Row submissions.  
• Experience of developing regulatory strategies to obtain marketing approvals and maintain regulatory compliance.   
• Lead a project as CMC regulatory leader. 

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 ‘Apply’ at the bottom or top of this advert. On submitting an application you will be asked to complete a profile which will include your CV, package details and other information in support of your application.

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.