Gi Life Sciences Basel
zuchwil
Team Leader Regulatory Affairs Manager Chemistry (all genders) – 100%
- 10 Juni 2026
- 100%
- Festanstellung
- Deutsch (Fliessend), Englisch (Fliessend)
- zuchwil
Über den Job
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
Einführung
Für einen Kunden in Zuchwil suchen wir eine motivierte Peron für die Stelle