Regulatory Specialist QA R&D (m/f/d)

We are a medium-sized, global pharmaceutical service company for the development and production of medicines from major global clients. We are now looking for a Quality Assurance R&D department

in parttime (up to 20 hours / week) Reference number: 5030 The job is limited to two years.

Self-assessment and coordination of worldwide authorisation activities and approval procedures for clinical trials of medicinal products with regard to pharmaceutical quality, within the responsibility of a wage manufacturer Timely creation and processing of documents on pharmaceutical quality for submission (including the creation of dossier parties and the creation of regulatory specifications and test methods) Processing of deficiencies within the framework of global authorisation procedures clarification of regulatory issues as part of development projects as a member of cross-functional teams Conducting regulatory guideline research and evaluating potential influences Installation and testing of internal change control processes as well as the approval-compliant execution of these processes including the creation of regulatory recommendations Examination of changes in GMP documents for authorisation relevance Participation in customer visits and support in audits

Successfully completed scientific studies, e.g. pharmacy, chemistry or comparable Ideally, at least five years of experience in the pharmaceutical industry with a position in quality management, preferably in regulatory affairs or quality assurance Consultant (m/w/d) for regulatory matters with sound knowledge of relevant quality standards and requirements, in particular EudraLex, 21 CFR Part 4, 210 and 211, ISO 13485, Medical Device Directive and Medical Device Regulation as well as ICH Guidelines Self-contained and structured mode of operation, rapid conception, cross-disciplinary thinking and pronounced detail accuracy Ability to analyse, understand and interpret regulations and standards Teamability and strong communicative competence as well as flexibility in changing requirements Knowledge gained in MS Office and SAP as well as initial experience with AI in the regulatory environment Very good knowledge of German and English in word and writing

An attractive and diverse task with further development potential in an expanding company with an international dimension, corresponding doping and good social services