Drug regulatory Kanton Waadt Jobs

Regen Lab SA based in Le Mont-sur-Lausanne. We are a Swiss leading medical device company comprised of a dynamic team dedicated to revolutionizing healthcare. Our commitment to innovation and excellence drives us to develop cutting-edge medical devices that positively ...

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 ...Switzerland and the successful candidate is required to be in the Canton of Vaud. In this role, you lead the development and improvement of the regulatory affairs capabilities in Europe, Middle East and Africa. You provide strategic guidance regarding the impact of regula...

Entreprise : Notre client est une entreprise internationale spécialisée dans le développement de dispositifs médicaux. Description du poste : * Collaborer à la réalisation du design avec les départements Marketing, Affaires Réglementaires et R&D * Etablir les spécifications...

 ...Job Description: As a Regulatory Affairs Manager you will be responsible for ensuring compliance with regulatory requirements related to...  ...and submit regulatory submissions including Investigational New Drug (IND) New Drug Application (NDA) 510(k) PreMarket Approval (PMA... 

 ...of registrations, renewals and lifecycle management; Review and validate products’ artworks and marketing campaigns to ensure regulatory compliance; Write and review SOP, WKI, FORM for regulatory affairs-related processes; Manage non-conformity process in particular... 

 ...innovation and excellence drives us to develop cutting-edge medical devices that positively impact patients' lives worldwide. Regulatory Affairs Manager Position Overview: For our site located in Le Mont-sur-Lausanne, we are seeking a highly skilled and motivated... 

 ...successful candidate is required to be in the Canton of Vaud.   In this role, you lead the development and improvement of the regulatory affairs capabilities in Europe, Middle East and Africa.  You provide strategic guidance regarding the impact of regulatory issues... 

 ...analytical methods remain compliant with MAAs / BLAs and with evolving regulatory requirements.  Ensure cross-product deployment of strategy....  ...success operating in a global matrix organization with the full breadth of functions contributing to drug development show more

 ...For Use (IFU) for our medical devices, ensuring compliance with regulatory standards. * Register medical devices in various regulatory...  ...the management of Instructions For Use for medical devices or drugs. * Familiarity with the structure of technical documentation and... 

 ...oversight of commercial manufacturing activities associated with Drug substance, Drug Product and primary packaged Product.   He...  ...Cooperate with the Supply Chain, Commercial Operations and Regulatory Affairs functions.   Requirements   Student in Bachelor... 

 ...recognized products. The new position of a Manager for Sterile Drug Product requires significant experience in manufacturing...  ...(FMEA) ~ Understanding of process engineering analytical and regulatory aspects of sterile drug product manufacturing Your solutionoriented... 

 ...at a newly ramped up Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for projects and New Product Introductions...  .../reports. Conduct and assist others in industry and regulatory research including research into industry standards/FDA guidelines... 

 ...industry ~ Thorough understanding of cGMPs and Swiss EU and FDA regulatory requirements Your tasks: * This position is responsible...  ...validation Experience in Data Integrity Good understanding of the drug development process from discovery through to regulatory filing... 

 ...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools... 

 ...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools... 

 ...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools... 

 ...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools... 

 ...biotechnologie, chimie ou un autre domaine Excellente maîtrise des procédés pharmaceutiques, de préférence de la production de drug substance biotechnologique Connaissance approfondie des activités de validation des procédés (analyse des risques, plan de validation... 

 ...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools...