Regulatory Affairs Specialist

1 week ago

Redwood City, California, United States REVOLUTION Medicines Full time
Revolution Medicines: A Leader in Precision Oncology

Revolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies for RAS-addicted cancers. Our R&D pipeline focuses on RAS(ON) Inhibitors and RAS Companion Inhibitors, designed to suppress diverse oncogenic variants of RAS proteins and enhance combination treatment strategies.

The Opportunity

The Senior Associate, Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operations and collaborate with global regulatory authorities. This role will represent Regulatory Affairs on project teams, coordinate submission requirements, and develop regulatory documentation for inclusion in submissions to global health authorities.

Key Responsibilities
  • Compile regulatory submissions that meet ICH or FDA requirements, local or regional regulatory requirements, and company policies and procedures.
  • Prepare and manage routine submissions and related activities, defining and managing detailed timelines to ensure timely delivery of high-quality, compliant, accurate, and complete regulatory submissions.
  • Assist in the development and implementation of SOPs and systems to track and manage product-associated events.
  • Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval.
  • Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
Requirements
  • Bachelor's degree in a relevant field.
  • Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
  • Some familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
  • Willingness to advance knowledge of regulatory practice through classes, certifications, webinars.
  • Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.
Preferred Skills
  • Experience in oncology drug development.
  • Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA's.
  • Excellent written and verbal communication skills.
Compensation and Benefits

The base salary range for this full-time position is $95,000 to $120,000 for candidates based at our headquarters in Redwood City, CA. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

We will only collect, process, and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy.

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