Senior Associate, Regulatory Affairs

Company: THIRD ROCK VENTURES, LLC
Location: Redwood City
Posted on: May 25, 2023

Job Description:

Senior Associate, Regulatory Affairs at Revolution Medicines Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities. Specifically, you will be responsible for: Assist and keep detailed timelines for regulatory activities and submissions and assure planning and coordination of activities, within the departments and working with other functions. Coordinate the content development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities. Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures. Prepare and manage routine submissions and related activities. 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. Assist in the development of regulatory strategy and update strategy based upon regulatory changes. Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects. Work with manager on acquisition and development of required regulatory skills and knowledge. Required Experience, Skills, and Education: 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. Willing 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. Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law. The expected salary range for this role is $100,000 to $135,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with ourCCPA Notice andPrivacy Policy .For additional information, please contactprivacy@revmed.com . Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with ourCCPA Notice andPrivacy Policy .For additional information, please contactprivacy@revmed.com .

Keywords: THIRD ROCK VENTURES, LLC, Redwood City , Senior Associate, Regulatory Affairs, Other , Redwood City, California