Senior Associate, Regulatory Affairs New Redwood City, California, United States
Revolution Medicines, Redwood City, CA, United States
Overview
Revolution Medicines is a late‑stage clinical oncology company developing novel targeted therapies for patients with RAS‑addicted cancers. Its 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), elironrasib (RMC‑6291), zoldonrasib (RMC‑9805), and RMC‑5127 are currently in clinical development.
Opportunity As a member of the Regulatory Affairs team, you will collaborate with multidisciplinary teams to identify submission requirements and coordinate the content and development process of regulatory documentation for inclusion in submissions to global health authorities.
Responsibilities
Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements and coordinate the content and 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, 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.
Function as the Subject Matter Expert (SME) of Clinical Trial Regulations (CTR) in the EU.
Function as the SME on the internal cross‑functional process for collecting and submitting investigator documents to INDs, including developing and providing training within teams.
Qualifications
Bachelor’s degree or equivalent in Biology, Pharmacy, Chemistry, or a related field.
Two (2) years of experience in Regulatory Affairs.
Experience working with FDA and ICH regulations and guidance.
Experience compiling, managing, and submitting regulatory submissions to global health authorities.
Experience working with an electronic Regulatory document information management system.
Experience conducting regulatory research to understand product classification requirements, regulatory frameworks, and submission pathways in assigned markets.
Experience maintaining regulatory documentation archives, registration databases, and tracking systems to support submission history and facilitate regulatory inspections.
Experience investigating and troubleshooting regulatory issues related to product and process compliance, and providing solutions to support product approvals and ongoing compliance.
Experience working with cross‑functional teams to address regulatory challenges and ensure regulatory requirements are met at each development stage.
Work Arrangement This position allows for a hybrid work arrangement; the employee must reside in the San Francisco Bay area and may work remotely two (2) days per week.
Compensation and Benefits Base pay salary range for this full‑time position (on‑site at Redwood City, CA) is $120,000 – $150,000 USD. Salary is determined by role, level, and location, and may be adjusted for local market. In addition to base pay, the role includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
EEO Statement 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.
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Opportunity As a member of the Regulatory Affairs team, you will collaborate with multidisciplinary teams to identify submission requirements and coordinate the content and development process of regulatory documentation for inclusion in submissions to global health authorities.
Responsibilities
Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements and coordinate the content and 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, 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.
Function as the Subject Matter Expert (SME) of Clinical Trial Regulations (CTR) in the EU.
Function as the SME on the internal cross‑functional process for collecting and submitting investigator documents to INDs, including developing and providing training within teams.
Qualifications
Bachelor’s degree or equivalent in Biology, Pharmacy, Chemistry, or a related field.
Two (2) years of experience in Regulatory Affairs.
Experience working with FDA and ICH regulations and guidance.
Experience compiling, managing, and submitting regulatory submissions to global health authorities.
Experience working with an electronic Regulatory document information management system.
Experience conducting regulatory research to understand product classification requirements, regulatory frameworks, and submission pathways in assigned markets.
Experience maintaining regulatory documentation archives, registration databases, and tracking systems to support submission history and facilitate regulatory inspections.
Experience investigating and troubleshooting regulatory issues related to product and process compliance, and providing solutions to support product approvals and ongoing compliance.
Experience working with cross‑functional teams to address regulatory challenges and ensure regulatory requirements are met at each development stage.
Work Arrangement This position allows for a hybrid work arrangement; the employee must reside in the San Francisco Bay area and may work remotely two (2) days per week.
Compensation and Benefits Base pay salary range for this full‑time position (on‑site at Redwood City, CA) is $120,000 – $150,000 USD. Salary is determined by role, level, and location, and may be adjusted for local market. In addition to base pay, the role includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
EEO Statement 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.
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