Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan mitochondrial and neuromuscular diseases, areas of high unmet medical need with no current therapies. We are looking for a GMP Compliance & Technical Regulatory Officer based at our Headquarters in Liestal outside of Basel, Switzerland. As Santhera has several development programs and regulatory filings ongoing and is preparing for the commercial launch of its lead product Raxone®/Catena® in and outside the EU, we are looking for someone to fill the position of a GMP Compliance & Technical Regulatory Officer. The responsibilities for this role include the following: Oversight of all GMP relevant processes internally and on collaboration with CDMOs/CMOs Acting as the Responsible Person for Switzerland according to AMBV §5.10.14 Management of the company’s GMP/GDP Quality Management System in accordance with company policies and HMG Art 6. (“Heilmittelgesetz”) incl. Site Master File etc. Batch release of drug substance, drug product and finished product batches Establishment and maintenance of GMP relevant documents including; Quality Agreements with GMP/GDP contractors and suppliers SOPs and other GMP/GDP compliance documentation Specifications, validation and transfer documents Deviation and investigation reports, change control and complaints Performance of internal and external GMP/GDP audits Serving as contact and responsible person for Health Authority inspections Design and implementation of Technical Regulatory strategy for development and approval of pharmaceuticals in the EU, North America and other countries Compilation of the CMC/Quality sections of IND/IMPD and NDA/MAA dossiers and changes/variations in a timely and accurate manner in compliance with internal policies and applicable regulations and standards Close collaboration with Regulatory Affairs and other functions within the company Support of the Technical Development & Operations functions As an ideal candidate for this role you should have/be Ph.D. in Chemistry, Pharmacy or equivalent 5+ years experience in the Pharmaceutical industry 3+ years experience in Quality Assurance / GMP Compliance 3+ years in Technical Regulatory and/or Technical Development Fluent oral and written English, German language is an advantage Excellent communication, organization and tracking skills Scientific and strategic thinking If you are interested please send your CV and motivation letter by email to: [email protected] Direct applicants only – no staffing companies please.
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