Senior Associate, Regulatory Affairs at Revolution Medicines

You're a Regulatory Affairs professional with at least two years of experience, holding a Bachelor's degree in a relevant scientific field like Biology or Chemi

Work type: hybrid

Location: Redwood City, California, United States

Salary: $120,000 – $150,000/yr

Type: Full-time

Summary

You're a Regulatory Affairs professional with at least two years of experience, holding a Bachelor's degree in a relevant scientific field like Biology or Chemistry, and you have experience with FDA regulations and ICH guidelines. **What makes it worth a look...** Revolution Medicines is offering a full-time, hybrid Senior Associate role in Redwood City, California, with a salary range of $120,000 - $150,000 per year. **You might be a good fit if you...** * Have experience working with regulatory requirements for drug and biological product development, including FDA and ICH guidelines. * Can compile, manage, and submit documentation to global health authorities. * Are proficient in using electronic regulatory document information management systems. * Have experience as a Subject Matter Expert in Clinical Trial Regulations (CTR) in the EU.

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.

• 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.

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.

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