Associate Director, Biologics CMC Regulatory Permanent Position

Hatfield - UK

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Associate Director Biologics CMC Regulatory - Permanent Position(4031)

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 an Associate Director Biologics CMC Regulatory you will provide CMC-Regulatory support on specific projects/queries relating to CMC for biologic projects/approved products including antibody drugs in development from a global perspective and strengthen the science and scientific arguments made in the Quality section of all submissions (IMPDs/lNDs briefing documents for scientific advice BLAs/MAAs variations and renewal activity for approved products etc.) made by Eisai.
To provide CMC expertise at Health Authority meetings.
To collaborate with IPT and CMC teams including manufacturing/QA etc. (commercial team members) to advance development projects/approved products toward submission/approval.
To 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

A bachelors degree (or equivalent with experience) in a Scientific or Technical Discipline; Advanced Degree (MSc. Ph.D MBA) preferred.
Extensive experience in the pharmaceutical industries with proven experience in CMC regulatory supporting new chemical entities and biologic products.
Working knowledge of the development and/or manufacture of small molecules and biologics (mAbs) compounds including characterisation comparability process validation control strategy and stability.
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 and justification.
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

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

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

Required Experience:

Director

Associate Director Biologics CMC Regulatory - Permanent Position(4031) The CompanyEisai 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 healt...