Date Posted:
May 21, 2026
Position Title:
Associate Director, Regulatory Operations
Office/Company:
Revolution Medicines
Party:
N/A
Office Code:
Job Number:
HC-07035
Reports To:
Location:
Redwood City, CA
Contact:
Salary:
$186,000 – $233,000 USD
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
Regulatory Operations and publishing experience in the biopharmaceutical industry; advanced degree preferred.Regulatory publishing & submission management, systems, tools & process optimization, cross-functional leadership & vendor oversight, strategic contribution & compliance.Bachelor’s degree in a life science, technical, or related field with 8+ years of Regulatory Operations and publishing experience in the biopharmaceutical industry; advanced degree preferred.
Responsibilities:
• Oversee the planning, preparation, publishing, submission, and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions.
• Manage submission production and quality control (QC) processes, ensuring compliance with global regulatory requirements and internal standards.
• Provide technical expertise in eCTD publishing tools and platforms (e.g., Veeva Vault RIM) to enable efficient and compliant submission execution.
• Proactively manage publishing timelines from request through archive, anticipating potential issues, escalating risks early, and collaborating with cross-functional teams to adapt plans as needed.
• Support the implementation, optimization, and maintenance of regulatory systems, tools, and technologies to improve submission efficiency and scalability.
• Partner with cross-functional stakeholders to ensure regulatory systems and workflows are well-documented, scalable, and aligned with business needs.
Qualifications:
• Expert-level proficiency in Microsoft Word, Adobe Acrobat Professional, Toolbox, and StartingPoint.
• Thorough understanding of eCTD publishing standards, submission formatting, transmission, and archiving regulations and guidelines.
• Experience preparing and submitting regulatory dossiers to multiple global Health Authorities; oncology experience is a plus.
• Demonstrated ability to manage and prioritize multiple FDA applications and submissions with overlapping deadlines while maintaining accuracy and compliance.
• Ability to anticipate risks and proactively identify solutions to potential publishing and submission challenges.
• Strong organizational skills with high attention to detail and the ability to work independently in a dynamic, fast-paced environment.
Instructions:
Email <ddress>
Other:
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.
