Associate Director, Biologics CMC Regulatory

Associate Director, Biologics CMC Regulatory

Eisai

United Kingdom

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 bachelor’s 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