Backed by GV.
About the role
The Associate Director of Regulatory Science may represent regulatory science on cross-functional teams and provide regulatory advice on clinical development matters. The candidate should have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 9+ years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs
- Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities
- Experienced in representing Regulatory Science on cross functional teams and presenting to senior management. Excellent communicator
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines
- Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred
- Direct experience with oncology drug development highly preferred
More about this role
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.
The Associate Director of Regulatory Science may represent regulatory science on cross-functional teams and provide regulatory advice on clinical development matters. The candidate should have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback, facilitate decision-making and...
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