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Team leader regulatory affairs manager chemistry – 100%

Zuchwil
Gi Life Sciences Basel
Director of Projects
Inserat online seit: Veröffentlicht vor 10 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:

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

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