Author high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance throughout project lifecycle. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents. 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 strategy, identifying the critical issues. 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.
Regulatory CMC Manager
Global pharma company
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
As per the industry
Regulatory experience preferred, and/or experience in drug/biopharmaceuticals. Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
Deutsch: Von Vorteil
Englisch: Sehr gut
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