Temp Director, Regulatory Affairs
Temp Director, Regulatory Affairs
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Not Disclosed
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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted pragmatic well-vetted consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development applicable regulations and current health authority thinking and have strong leadership and relationship-building ability.
Provide clear effective regulatory strategy as the Regulatory Study Lead for global oncology programs.
Motivate mentor and develop direct reports to ensure development and performance.
Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.
Develop robust global regulatory strategies that reflect competitive intelligence expert input and align with corporate goals to ensure global success.
Drive consistency in regulatory approach ensuring lessons learned across programs are applied broadly.
Establish highly collaborative and effective relationships with management colleagues in Clinical Research Clinical Operations Regulatory Affairs Medical Writing Quality and other functions to ensure cross-functional alignment and team effectiveness.
Required Skills Experience and Education:
Degree in life sciences pharmacy medicine or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
Proven success in developing and delivering global regulatory strategies and submissions.
Demonstrated success in leading health authority interactions and negotiations.
Direct experience in oncology drug development including oversight of large global Phase 3 and platform studies.
Strong track record in alliance management coordinating with external development or commercialization partners.
Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
Excellent communication planning and organizational skills with the ability to manage multiple projects and tight deadlines.
Preferred Skills:
An advanced degree is desirable.
Experience with dose optimization in oncology.
Prior NDA experience is highly preferred.
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.
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Required Experience:
Director
Employment Type
Temp
