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)