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Team leader regulatory affairs manager chemistry – 100%

Solothurn
Gi Life Sciences Basel
Director of Projects
EUR 105’000 pro Jahr
Inserat online seit: Veröffentlicht vor 19 Std.
Beschreibung

Für einen Kunden in Zuchwil suchen wir eine motivierte Peron für die Stelle


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:
o Maintaining worldwide REACH compliance, including substance registrations, exposure scenarios, compliance documentation, and supply chain communication
o Classifying substances and mixtures according to CLP regulations and international regulatory requirements, taking harmonized classifications and local legislation into account
o 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
o 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
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