Senior CMC Consultant

Senior Regulatory CMC Consultant

Remote

CPL Life Sciences are collaborating with a global pharmaceutical business focused on the discovery, development, and commercialization of innovative medicines.

As a Senior Regulatory CMC Consultant, you will be responsible for the development of CMC Strategy for a range of projects in the development phase including the preparation of CMC submissions for investigational products to key regulatory agencies such as the FDA and EMA.

1. Define Regulatory CMC strategy for a variety of projects in development.
2. Preparation of CMC submissions for the EU and US.
3. Oversight of CMC documentation preparations (Module 2,3).

1. Bachelor's degree or higher in Life Sciences or technical field and around 4+ years of experience in pharmaceuticals or a related industry. Advanced degree preferred.
2. Experience working with biologics in development phases.
3. Small Molecules and Biologics experience.
4. CMC focus.

This is a great opportunity to join a rapidly growing drug development Pharma that is very well-funded and is looking to grow further in the next year. The role comes with a great benefits package as well as working within a very established team. The role has the flexibility to be fully remote across the UK, Ireland, and Malta.

If you are interested in this role or would like more details please email your CV to .