Director CMC

3 months ago


Hatfield, United Kingdom Pharmiweb Full time
Job description:

Director CMC - Permanent Position

The Company

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.
By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.


Your new role

As a Director, CMC you will be responsible and accountable for CMC sections of Eisai regulatory submissions related to biologics products (clinical and commercial stage), all regions globally.
Main duties include, but not limited to: 

  • Manage, prepare, finalise CMC sections of EU IMPD/MAA and rest of world equivalent documents.  
  • Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior management, ensure on time delivery of high-quality submission documents.


What are we looking for?

  • Demonstrated experience with preparation of major biologics submissions, multiple IMPD submissions, MAA submissions
  • Demonstrated experience with biochemistry, especially antibody and immune system biological processes.
  • Advanced degree preferred


What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes,

  • Hybrid working (Depending on role)
  • Car/Car Allowance (Depending on role)
  • Electric charging points for Electric/Hybrid vehicles
  • Discretionary Bonus
  • Free onsite parking
  • Subsidised onsite restaurant and coffee shop
  • Learning and development opportunities
  • Retail discounts
  • Well-being & mental health awareness programmes 
  • Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.


What you need to do next 

If you are interested in this position, please click ‘apply now’ at the top of this advert. Upon submitting your application, you will be asked to complete your profile, and upload a copy of your CV along with any additional information to support your application. 
If you have any questions, please contact us on TalentAcquisition@eisai.net 

 

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.


Eisai EMEA EDI Commitment Statement 

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society. Our commitment is: 

  • to embrace and celebrate our differences, respecting and valuing each other. 
  • to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging. 
  • to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity