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Team leader regulatory affairs manager chemistry – 100%

Zuchwil
Gi Life Sciences Basel
Director of Projects
Inserat online seit: 11 Juni
Beschreibung

Für einen Kunden in Zuchwil suchen wir eine motivierte Peron für die StelleTeam Leader Regulatory Affairs Manager Chemistry (all genders) – 100%Your ResponsibilitiesProviding both technical and personnel leadership for the Regulatory Affairs departmentActing as deputy to the Director RQSEnsuring global regulatory compliance of products based on expert knowledge and collaboration with local stakeholders, including:Maintaining worldwide REACH compliance, including substance registrations, exposure scenarios, compliance documentation, and supply chain communicationClassifying substances and mixtures according to CLP regulations and international regulatory requirements, taking harmonized classifications and local legislation into accountCreating, maintaining, and managing Safety Data Sheets (SDS) for existing and new formulations in line with international standards, and ensuring availability for production, laboratories, and customersCoordinating and implementing GHS reclassifications, including updates to labels and systems, while assessing the impact on product regulatory complianceCommunicating with relevant authorities and serving as the designated contact person for chemical regulationsSupporting development projects by integrating regulatory requirements at an early stageActing as system owner for the chemical database, including maintenance, change assessments, and continuous improvementsCreating and maintaining formulations and products in ChemGes software, as well as managing related ERP master dataYour ProfileDegree in Chemistry, Pharmacy, or a related scientific fieldStrong regulatory expertise in chemicals legislation (e.G., CLP/GHS, REACH, dangerous goods regulations); knowledge of medical devices is an advantageFamiliarity with quality management systems such as ISO 9001 and ISO 13485Proven experience in stakeholder and interface management, including communication with regulatory authoritiesLeadership experience, including team development and fostering a feedback cultureExperience in scientific and regulatory writingFluent German and English skills (B2–C1 level)Basic IT and system knowledge jid48fdcf0a jit0624a jiy26a

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