Temp Director of Regulatory Affairs, Business Excellence
Temp Director of Regulatory Affairs, Business Excellence
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Salary Not Disclosed
1 Vacancy
Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Director of Regulatory Affairs Business Excellence role provides strategic operational support to the Head of Regulatory Affairs and their leadership team by strengthening execution improving processes and ensuring compliance across department activities. Focused on operational execution aspects of the Regulatory Affairs department the role helps ensure regulatory processes and governance are effective compliant and aligned with expectations. The ideal candidate is a collaborative problem-solver who brings structure to complex work and drives meaningful change through process design project oversight and leadership engagement.
Advance the priorities of the Head of Regulatory Affairs and the Regulatory Leadership Team (RegLT) by supporting business and department operations initiative planning and execution. Provide input on ongoing projects resource utilization and operational alignment across the department while helping refine regulatory processes standards and capabilities to meet global and cross-functional objectives.
Manage RegLT meetings and department initiatives including planning agenda development logistics scheduling and tracking of action items through completion.
Lead the Regulatory Working Group composed of RegLT direct reports to align cross-functional policies procedures and priorities. Provide regulatory guidance drive decision-making and ensure timely execution of action items in coordination with the RegLT.
Manage and consolidate input for resource decision support including headcount budget and resource utilization tracking.
Represent Regulatory Affairs in cross-functional efforts to develop review and maintain regulatory processes and procedural documents (e.g. work instructions RACIs). Coordinate with stakeholders and subject matter experts to ensure sufficient input and buy-in on regulatory policies and procedures while maintaining consistency and compliance with corporate policies and global regulations.
Develop write maintain and revise department-level SOPs and other regulatory procedural documents in compliance with company-wide policies and regulatory requirements.
Coordinate the development and rollout of training for changes to regulatory processes and ways of working including onboarding program.
Build and maintain strong internal and external networks through a regulatory lens to gather insights share best practices and support regulatory-focused initiatives that drive business excellence.
Inspire and promote a culture of innovation collaboration and performance excellence across Regulatory Affairs.
Required Skills Experience and Education:
Minimum of 710 years of experience in Regulatory Affairs emphasis in business operations or project/process management in the life sciences industry.
Strong understanding of regulatory processes and compliance frameworks; experience with SOP development and maintenance preferred.
Proven project and change management capabilities including planning execution and stakeholder communication.
Demonstrated ability to lead through influence drive alignment and manage competing priorities.
Excellent interpersonal organizational and communication skills.
Strong strategic thinking and analytical mindset with attention to detail.
Preferred Skills:
Experience with audit/inspection readiness and regulatory documentation systems.
Proficiency in MS Office Suite Smartsheet or similar project/portfolio tools.
This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range which will be based on several factors including job-related skills experience market conditions and relevant education or training.
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 the 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 additional information please contact. #LI-Hybrid #LI-AP1
Required Experience:
Director
Employment Type
Temp
