Director, Regulatory Affairs US Filing Lead
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Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
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 (US Filing Lead) is accountable for driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier ensuring cross-functional coordination and effective communication across Regulatory Clinical Biostatistics CMC Quality Translational Medicine and Commercial. The Director will support drug development teams and ensure delivery of targeted pragmatic well-vetted consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development US NDA regulations current Health Authority thinking and have strong leadership & problem-solving ability.
Reports into Regulatory Affairs Global Filing & Registration
High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.
Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.
Develop strategic filing plans under expedited regulatory pathways programs and developing Health Authority initiatives.
Coordinate NDA Filing and Sub-team rosters for management endorsement.
Lead cross-functional NDA kickoff according to global filing plans and framework.
Maintain & track an integrated filing plan including regulatory timelines modular NDA deliverables critical path activities in concert with Regulatory Program Management.
Identify respond to and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management.
Drive and/or support modular NDA Sub-teams (e.g. across Clinical Non-Clinical Product Label etc.) to ensure consistent communication timely data delivery and issue resolution.
Lead relevant Health Authority meetings interactions and query responses and coordinate cross functional team preparation & involvement.
Motivate mentor and develop direct reports to ensure development and performance.
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 a regulatory strategy role.
Proven success in executing US NDAs (preparation submission & approval)
Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.
Demonstrated ability to lead Health Authority interactions and negotiations.
In-depth knowledge of CTD structure and management of dossier components.
Direct experience in oncology drug development including oversight of large global Phase 3 registrational studies.
Flexibility to support business needs of dynamic registrational programs.
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.
#LI-Hybrid #LI-JC1
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.
Revolution Medicines takes 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.
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
