Main Responsibilities include, but are not limited to:

* Formulation and development activities, manufacture, quality control and release of Drug Substance and Drug Product for use in pre-clinical and clinical studies
* Issuing development reports, CMC documentation etc.
* Selection, qualification and follow-ups of CRO’s, CDMO’s and Consultants as appropriate
* Preparation of regulatory documentation for clinical trial applications
* Development and manufacture that are conducted in accordance with regulatory requirements (EMA/FDA, GMP, ISO, lCH etc) and clinical trial applications (IMPD, IND)

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