Senior Regulatory CMC Expert

3 weeks ago

London, Greater London, United Kingdom CPL Healthcare Full time

CPL Healthcare is seeking a highly skilled Senior Regulatory CMC Expert to join their team. As a key member of the CMC Strategy team, you will be responsible for developing and implementing CMC strategies for a range of projects in the development phase.

Key Responsibilities:

  1. Define and implement CMC strategies for various projects in development.
  2. Prepare and submit CMC documentation to regulatory agencies such as the FDA and EMA.
  3. Oversee the preparation of CMC documentation, including Module 2 and 3.

Requirements:

  1. Bachelor's degree or higher in a Life Sciences or technical field, with a minimum of 4+ years of experience in pharmaceuticals or a related industry.
  2. Experience working with biologics in development phases.
  3. Strong understanding of CMC regulations and guidelines.

This is a fantastic opportunity to join a rapidly growing pharmaceutical company and contribute to the development of innovative medicines. The role offers a great benefits package and the flexibility to work remotely across the UK, Ireland, and Malta.

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