An NSF International Company CMC Regulatory Writer
Samsung Bioepis.
Location: Incheon, South Korea
Salary: Competitive
Date added: 17th November 2014
Summary job description
- Authoring and editing of CMC and non-clinical part in CTD, IMPD and relevant regulatory dossier
- Advice on submission strategy in terms of content requirements
- Positioning of key messages within the submission
- Review and provide advice on technical documents required to support submission
- Advice on strategic input, messaging of key responses for Agency questions.
Required education: MSc. or Ph. degree in biochemistry, molecular biology or relevant life-science area.
Required language skill: fluent in English (native speaker).
Experience: minimum 5 years of experience as CMC regulatory writer or minimum 7 years of experience in CMC regulatory affairs within a biopharmaceutical company.
Contact details:
Boudy Konig, Samsung Bioepis.
emaiI [email protected]
cellular phone: +821 071886911
