Agensi Pekerjaan CityRecruit Sdn Bhd
Nusajaya, Johor, Malaysia
07 Dec, 2018
Full time
Role/Job Description: (to be filled by the proposer) 1) Understanding about Biosimilar development program 2) Knowledge about Biosimilar Regulatory requirements eg; ICH, USFDA, EMA etc. 3) Ability to support and review for analytical and technology transfer activities 4) Ability to write and review the high quality CMC part of the dossier 5) Preparation of product registration dossiers in ACTD/ ICH CTD format and any other country specific formats 6) Review the documents from various validation exercise and study protocols required to support product registration 7) Providing the data to various customers and partners after the internal review and maintain registration trackers 8) Understanding the various export market requirements 9) Preparation of DMF for Drug substances 10) Preparation and submission of site registration application 11) Coordination of external audits/ visits 12) Interacting with various cross functional teams for monitoring the progress of the project 13) Creating and maintaining the database of the received documents 14) Preparing the submission related summaries from the study reports and approved documents 15) Maintaining the archival of the various communications/ submission documents
