Senior Associate, Regulatory Affairs

Title: Senior Associate, Regulatory Affairs

Location: Redwood City, CA, United States

Hybrid

Job Description:

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; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-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.

The Opportunity:

• Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.

• 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.

• Function as the Subject Matter Expert (SME) of Clinical Trial Regulations (CTR) in the EU.

• Function as the Subject Matter Expert on the internal cross functional process for collecting and submitting investigator documents to INDs.

• This includes developing and providing training within teams.

Required Skills, Experience and Education:

• Bachelor's degree or equivalent in Biology, Pharmacy, Chemistry or related. 

• Two (2) years of experience in Regulatory Affairs.

• Internship or work experience to include:

• Working with regulatory requirements for development of drug and biological products including FDA (Food and Drug Administration) regulations and guidance and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines;

• Compiling, managing and submitting submissions to global health authorities;

• Working in an electronic Regulatory document information management system;

• Conducting regulatory research in assigned markets to understand product classification requirements, regulatory frameworks, and submission pathways;

• Maintaining regulatory documentation archives, registration databases, and tracking systems to support submission history and facilitate regulatory inspections;

• Assisting in investigating regulatory issues related to product and process compliance, troubleshooting, and providing solutions to support product approvals and ongoing compliance;

• Working with cross-functional teams to address regulatory challenges and ensure regulatory requirements are met at each development stage.

• Successful completion of background and employment history verification required.

• 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.

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range 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 our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

Base Pay Salary Range

$120,000—$150,000 USD

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