Temp 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 Revolutionaries 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.

• 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.

• 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. Define and manage 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. 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 Skills, Experience 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 my 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 NDAs.

• Excellent written and verbal communication skills.

This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.

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 the 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 [email protected]. #LI-Hybrid  #LI-AP1