REGULATORY AFFAIRS SENIOR MANAGER

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fn2sr

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D; pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. We are seeking a highly motivated and experienced professional to join our team as a Senior Director, Regulatory Affairs, Italy. Key aspects of this role will include leading and providing strategic input on all regulatory activities for assigned projects and territories in accordance with ICH requirements, Italian and EU regulations, and scientific and company policies and procedures.



The role will work cross-functionally with regulatory professionals at global and European level, supporting both early-stage and marketed products. This role will further ensure compliance with the applicant's and/or marketing authorization holder's responsibilities under legislation or regulatory guidelines for assigned products in Italy.
The Senior Director Regulatory Affairs is an essential member of the local Management Team, while also acting as a strong and active member of the International Regulatory Team. The candidate will provide regulatory support for assigned products and therapeutic areas and work cross-functionally with medical affairs, clinical development, marketing and other teams to support the development and execution of medical strategies and tactics.
Support global and regional RA as applicable with the preparation and follow-up for national scientific consultations and pre-submission meetings.
coordination of the creation of materia

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fn2sr