Found Description
Make your mark for patients
We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Slough (UK) or Raleigh/Atlanta (US) offices.
About the role
Define the strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing applications, variations) from a global/regional perspective to achieve timely approvals to meet business needs.
Who you’ll work with
You will work within the Regulatory CMC team and partner with other technical and regulatory functions across the business.
What you’ll do
Responsible for regional and global CMC submissions in line with agreed global regulatory strategy, and within agreed timelines.
Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regio...