Hiring: Director, Regulatory Affairs (US Filing Lead) Company: Revolution Medicines Location: San Francisco Bay Area Job Posted Time: 2026-09-10 11:48:19 Employment Type: Full-time Target Skills & Keywords : Program Management About the job Experience: •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. Required Skills: •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. Qualifications: •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. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!