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 Freddie.hill@pharma-partners.co.uk