I have a background within natural science (M.Sc., Biology) and more than 20 years of experience from the pharmaceutical industry including QC, process support and more than 15 years in Regulatory Affairs CMC. My experience from QC and process support gives me an in-depth understanding of the CMC processes, which is a huge benefit when discussing regulatory CMC-strategies and preparing regulatory CMC documents.
Salamon RA-CMC
Salamon RA-CMC
Marianne Brandt Salamon
Hovedkompetencer
- In-depth knowledge of and experience with regulatory CMC requirements worldwide.
- Preparation of CTD Module 2 and 3 documents; including coordinating and planning, writing, reviewing, and compiling.
- Providing input to CMC content level and documentation package for LCM: variation applications and amendments.
- Handling of Q&A processes; providing input to response strategies, coordinating process, writing, and reviewing response documents.
Kontaktinfo
Telefon nr.
4560683733
4560683733
E-mail
Salamon-ra-cmc@outlook.com
Salamon-ra-cmc@outlook.com