Under supervision, provide timely preparation of high quality CMC regulatory
documentation and support to contribute to global regulatory submissions and
The following tasks are to be performed as assigned:
Author high-quality CMC documentation for HA submission, with support and
guidance, applying agreed CMC global regulatory strategies, assuring technical
congruency and reg-ulatory compliance, meeting agreed upon timelines and
e-publishing requirements throughout project lifecycle.
Prepare CMC responses to health authority questions during development,
registration and product lifecycle.
Identify the required documentation for global submissions and negotiate the
delivery of approved technical source documents in accordance with project
Identify content, quality and/or timeliness issues with source documents, or
any other po-tential authoring issues that may impact submission quality or
timelines, as early as possi-ble.
Keep knowledge up to date with regard to regulatory guidelines and
requirements in all global regions as well as for new technical trends.
Actively participate as a member of the global team by contributing to the
regulatory strat-egy, identifying the critical issues and lessons learned.
Establish and maintain sound working relationships with partners and
Assume activities in support of the general department such as DRAGON
support, annual and product renewal writing, coordination/collection/storage of
source documentation needed for direct submission to HAs, other database entry
activities (specialized depart-ment functions).
Key Performance Indicators :
Timeliness of deliverables: No delays in approvals of clinical studies,
global registration dossiers or variations due to late or inadequate
documentation on matters within CMC control.
No last minute source document issues identified that could have been
prevented by early review of source documents.
Ensure that CMC regulatory documentation follows Novartis guidelines and
meets regulatory guidelines, as appropriate (e.g. measured by approval of CMC
documentation, and no non-approvals due to CMC issues under our control).
Positive customer feedback.
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology,
Biology) or equivalent