Associate Director, Regulatory Science
The Opportunity:
The Associate Director of Regulatory Science may represent regulatory science on cross-functional teams and provide regulatory advice on clinical development matters. The candidate should have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.
Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior personnel concerning risks.
Plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives.
Able to proactively identify risks and devise mitigation strategies.
Function as a Regulatory Science subject matter expert member of cross-functional teams, including study teams and submission teams.
Perform regulatory research to inform business strategy. Assess and communicate risks.
Assure that there are no significant interruptions to the business due to regulatory compliance issues.
Required Skills, Experience and Education:
Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 9+ years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.
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 Science 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.
Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred.
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.
#LI-JC1 #LI-Remote
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.
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Base Pay Salary Range
$177,000—$221,000 USD