Associate Director, Regulatory Affairs - Futureshaper.com : Job Details

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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Associate Director of Regulatory Science will provide regulatory support to clinical development programs in oncology. They will represent Regulatory Science on cross-functional teams and provide targeted & actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, provide clear and concise feedback to management and project teams, and facilitate decision-making to ensure successful regulatory outcomes. Specifically, responsibilities include, but are not limited to:

• Drive development & implementation of regulatory policies and procedures in support of global expansion and marketing application planning, submission and lifecycle management.

• Research regulatory requirements and identify relevant precedents to develop well-vetted, actionable strategies across regions for assigned programs. Translate strategy into specific activities supporting product development and corporate goals.

• Independently plan, prepare, and coordinate regulatory submissions to Health Authorities, ensuring high quality and timeline adherence as needed.

• Establish highly collaborative and effective cross-functional relationships and consult on the content, review and execution of regulatory documentation.

• Prepare and present regulatory topics and strategies for consideration at Company governance forums.

• Ensure consistency/completeness/adherence to standards for all regulatory submissions

• Support non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.

• Manage direct report(s) and provide mentorship to junior professionals as applicable.

Required Skills, Experience and Education:

• Bachelor's degree in life sciences, chemistry, or related discipline. Advanced degree preferred.

• Have 5–7 years of industry experience in biotech and/or pharma, with at least 4 years' experience in Regulatory Affairs.

• In-depth knowledge of international regulatory requirements (US, EU UK, and Japan preferable) including late-stage clinical development, and planning & preparation for submission of global marketing applications.

• Experience developing and implementing successful global regulatory strategies in a fast-paced environment.

• Experience in the preparation and submission of large, complex regulatory documentation to support Health Authority review/approval procedures, and post approval activities.

• Experienced representing Regulatory Affairs on cross-functional teams and presenting to senior management.

• Excellent planning, organizational and presentation skills and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Skills:

• Experience with combination studies, multiple expansion cohorts, basket or umbrella master protocols highly preferred.

• Direct experience with FDA and Health Authority expedited programs highly preferred.

• Oncology experience is preferred.

The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that 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 NoticeandPrivacy Policy.For additional information, please [email protected].

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