Are you an experienced professional in the field of pharmaceutical regulation?

A global pharmaceutical giant is seeking an experienced Senior Regulatory Executive with proven experience authoring CMC regulatory documents. You will be working closely with other senior personnel to coordinate multiple project teams across multiple sites, ensuring global CMC applications meet vigorous standards. This role will be mostly remote but you will be occasionally required to visit the site in West London.

Your responsibilities will include:

• Managing CMC authoring and approval for EU and EMAP regions
• Identifying opportunities for improvement in CMC regulatory processes
• Interacting with customers and senior stakeholders to manage the regulatory processes
• Identifying and managing risks associated with submission of CMC regulatory documents

The ideal candidate will have:

• Post approval CMC experience
• Experience authoring module 3 CMC
• Experience working with EU and EMAP regulations
• Ability to identify opportunities to streamline and improve CMC regulatory processes
• Excellent written and verbal communication skills
• Demonstrable experience working in a pharmaceutical environment

If this role is of any interest, or you would like to discuss a move into regulatory roles, please contact Helen on [email protected]

Tagged as: CMC, cmc regulation, Module 3, post approval cmc, regulatory executive