Responsibilities will include, but are not limited to, the following:
1 Assist in the review and coordination of Chemistry, Manufacturing and Controls (CMC) documentation for CTN, NDA/sNDA(including MCN), Drug Master Files(DMFs), CTD and MBL regulatory filings as assigned.
2 Raise with relevant line functions to ensure CMC documentation meets health authority regulatory CMC requirements and is in alignment with global regulatory CMC strategy.
3 Review and coordinate preparation of CMC section of CTN and NDA/sNDA annual reports as assigned.
4 Coordinate CMC documentation/information to satisfy local regulatory requirements for the release of clinical supplies and/or marketed product.
5 Assist in the development of internal guidelines for the preparation and maintenance of regulatory submissions.
6 Review and assess global regulatory impact of CMC changes relating to regulatory filings (change control).
7 Evaluate regulatory impact of GMP compliance and validation issues.