Full-Time

Associate Director

Regulatory Operations

Posted on 6/6/2024

Revolution Medicines

Revolution Medicines

201-500 employees

Specializes in precision oncology therapies

Biotechnology

Senior

San Carlos, CA, USA

Required Skills
Word/Pages/Docs
Requirements
  • 8+ years of Regulatory Operations and publishing experience
  • Expert level proficiency of MicroSoft Word, Adobe Acrobat Professional, Toolbox, StartingPoint
  • Thorough understanding of eCTD and relevant submission formatting, transmittal and archiving regulations and guidelines; detail oriented and highly organized
  • Knowledge of ex-US eCTD submissions and submissions processes
  • Successfully manage and prioritize multiple FDA applications and submissions deadlines with relative independence
  • Foster strong collaborative relationships with external partners and vendors to ensure both high quality of submissions and compliance with regulatory processes and standards
  • Outstanding interpersonal and communication (written and verbal) skills: able to work with multiple groups of people at one time, remaining calm, professional, diplomatic and positive
Responsibilities
  • Manage the production, quality control (QC), delivery and lifecycle of submissions in eCTD format for multiple FDA applications in various drug development phases
  • Provide expertise in MS Word to format submission documents, including but not limited to creating TOCs, render documents to PDF, bookmark, hyperlink, manage styles, maintain templates
  • Provide expertise in Adobe to PDF Process and format files to be eCTD compliant including but not limited to clean pages, edit document properties, use hyperlink & bookmark auditor to modify attributes, PDF optimize (Fast Web), skew pages, scaling, images resize and optical character recognition (OCR), and Preflight
  • Proactively manage multiple and overlapping publishing timelines from initial submission request through archive, anticipating potential delays and working with the teams to communicate and adapt
  • Effectively manage publishing vendors, consultants, and direct report(s) to support teams and appropriately adjust resources in a dynamic environment
  • Work with multiple departments across clinical, quality (CMC), and nonclinical to track the creation, versions, organization, review and approval of numerous regulatory documents with competing deadlines
  • Train teams on procedures, tools, and infrastructure for effective and efficient regulatory publishing
  • Maintain writing resources to ensure that submission documents across functional areas meet internal and health authority standards; resources include style guide, document checklists, and Starting Point templates
  • Perform gap analysis of regulatory operation policies, processes, and SOPs and initiate activities to support compliance, departmental efficiency, and use of systems
  • Maintain knowledge of the technical landscape, regulatory operations environment, regulations, and eCTD guidance, providing interpretation to internal stakeholders
  • Perform other duties, as needed

### Welcome to Revolution Medicines, crafting the future of oncology with precision. Our focus is on advancing RAS(ON) inhibitors and RAS Companion inhibitors, marked by the remarkable journey of our lead product, RMC-4630, through its clinical phases. Supported by a team of passionate oncology experts, we are steadfast in our mission to develop treatments that precisely target oncogenic mutations, promising a brighter, healthier tomorrow for patients everywhere. ###

Company Stage

IPO

Total Funding

$1.3B

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

18%

1 year growth

48%

2 year growth

98%