Lavoro Drug regulatory Losanna VD

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 ...

 ...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...

 ...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... 

 ...oversight of commercial manufacturing activities associated with Drug substance, Drug Product and Britestock. He/She assures...  ...according to Incyte audit program, Support the RA-CMC group for regulatory submissions and follow-ups, Ensure inspection readiness at assigned... 

 ...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... 

 ...on the development, implementation, and continuous improvement of the quality system in compliance with ISO 13485. She/He also works closely with the R&D and the production teams to ensure that the documentation meets all regulatory and medical requirements. Respons...

 ...compliance with ISO 13485. She/He also works closely with the R&D and the production teams to ensure that the documentation meets all regulatory and medical requirements. Responsibilities and Duties Reporting to the Quality, Regulatory and Clinical Affairs Manager... 

 ...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... 

 ...including related KPI is a key area to enhance existing processes. ~ Create configure and develop electronic manufacturing processes (Drug Substance Fill/Finishing Shared Services Plant Logistics) Prepare specifications and related design documents Oversee the... 

 ...with strict attention to detail. ~ Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR). ~ Excellent communication skills and interpersonal relationship skills including negotiating and... 

 ...biotech engineer pharmaceutical engineer process engineer chemist etc.) Experience in the field of biotechnology production of Bulk Drug Substance GMP experience Good MSOffice knowledge Ability to work in a fast paced high regulated environment French and... 

 ...100% Imm. CHF 110000 Tasks Review negotiate and draft commercial contracts Provide support on all legal matters incl. GDPR regulatory Intepret existing agreements providing guidance on obligations potential disputes Collaborate with crossfunctional teams to... 

 ...and ensure compliance with project requirements. • Work closely with cross-functional teams, including engineering, operations, regulatory affairs, and quality assurance, to ensure alignment with project goals • Communicate project progress and challenges to... 

 ...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... 

 ...Qualification (PQ) for  computerized systems. • Maintain comprehensive documentation for all CSV activities, ensuring adherence to regulatory standards and internal quality procedures. • Collaborate with quality assurance teams to support regulatory inspections and...