The Opportunity:

The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology. They will independently represent regulatory affairs 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, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes. Specifically, you will be responsible for:

• Research regulatory requirements and identify relevant precedents to develop well-vetted, actionable strategies for assigned programs. Translate strategy into specific activities supporting product development and corporate goals.
• Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
• Establish highly collaborative and effective relationships with colleagues in Clinical Research, Clinical Operations, Regulatory, Medical Writing, and other functions to ensure alignment and team effectiveness.
• Responsible for maintaining and applying a working knowledge of the dynamic regulatory landscape in oncology and translating this into actionable steps.
• Manage direct report(s) and provide mentorship to junior professionals.

Required Skills, Experience and Education:

• Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree is desirable with a minimum of 10+ years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 7 years in Regulatory Affairs.
• Direct experience with immuno-oncology drug development and checkpoint inhibitors highly preferred. Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.
• Direct experience with FDA expedited programs highly preferred.
• Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.
• Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.
• Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management. Excellent communicator.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Skills:

• Direct experience with oncology drug development highly preferred.
• Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.
• Direct experience with FDA expedited programs highly preferred.
• Direct experience with NDA filing highly preferred.

#LI-JC1 #LI-Hybrid

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.

Base Pay Salary Range

$186,000-$233,000 USD

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