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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

June Racchi

Gi Life Sciences Basel

Team Leader Regulatory Affairs Manager Chemistry (all genders) – 100%