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Team leader regulatory affairs manager chemistry (all genders) – 100%

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

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 (, 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

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