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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 Stelle
Team Leader Regulatory Affairs Manager Chemistry (all genders) – 100%
Your Responsibilities
Providing both technical and personnel leadership for the Regulatory Affairs department
Acting as deputy to the Director RQS
Ensuring 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 communication
Classifying substances and mixtures according to CLP regulations and international regulatory requirements, taking harmonized classifications and local legislation into account
Creating, maintaining, and managing Safety Data Sheets (SDS) for existing and new formulations in line with international standards, and ensuring availability for production, laboratories, and customers
Coordinating and implementing GHS reclassifications, including updates to labels and systems, while assessing the impact on product regulatory compliance
Communicating with relevant authorities and serving as the designated contact person for chemical regulations
Supporting development projects by integrating regulatory requirements at an early stage
Acting as system owner for the chemical database, including maintenance, change assessments, and continuous improvements
Creating and maintaining formulations and products in ChemGes software, as well as managing related ERP master data
Your Profile
Degree in Chemistry, Pharmacy, or a related scientific field
Strong regulatory expertise in chemicals legislation (e.g., CLP/GHS, REACH, dangerous goods regulations); knowledge of medical devices is an advantage
Familiarity with quality management systems such as ISO 9001 and ISO 13485
Proven experience in stakeholder and interface management, including communication with regulatory authorities
Leadership experience, including team development and fostering a feedback culture
Experience in scientific and regulatory writing
Fluent German and English skills (B2–C1 level)
Basic IT and system knowledge jid48fdcf0a jit0624a jiy26a

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