Senior Manager, Regulatory CMC

Job title: Senior Manager, Regulatory CMC

A pharmaceutical business in London are seeking a Senior Manager, Regulatory CMC to join their team. The role will be responsible for providing CMC regulatory support for established products including growth market submissions and any post-approval activities relevant.

Responsibilities:

• Collaborate with IPT and CMC teams supporting development projects towards license submission and approval.
• Preparation of regulatory roadmaps and gap analysis for the development of biosimilars up to approval.
• Provide CMC expertise cross functionally.
• Report on regulatory progress and issues for new products or LCM activities at all project team and Project Review Meetings, and to Senior Management as required.

Requirements:

• Experience in CMC Regulatory within the pharmaceutical or biotechnology industry
• Experience with Small Molecules is a must have and any experience in Biologics would be a bonus.
• Experience interacting with EU regulatory authorities – Scientific advice meetings/ Pre-submission meetings.
• Degree in Life Sciences would be beneficial

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via