KEY RESPONSIBILITIES Authoring of CMC sections (Drug Product and/or Drug Substance) for new registration applications in CTD format, in alignment with global regulatory strategies and current regulatory guidelines. Authoring and reviewing CMC documentation to support variations and commitments
Authoring of CMC sections (Drug Product and/or Drug Substance) for new registration applications in CTD format, in alignment with global regulatory strategies and current regulatory guidelines. Authoring and reviewing CMC documentation to support variations and commitments resulting from