Associate Director, reputed company Regulatory Affairs job at reputed company in Redwood reputed company, CA or US National

Title: Associate Director, reputed company Regulatory Affairs Location: Redwood reputed company, California/ reputed company Job reputed company: reputed company is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. reputed company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. reputed company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the reputed company team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. reputed company: reputed company is seeking an Associate Director, reputed company Regulatory Affairs to partner closely with the cross-functional teams to ensure that reputed company promotional and medical communication strategies are compliant with applicable regulations, industry standards, and internal policies. This role will help reputed company successful product commercialization while upholding regulatory reputed company and scientific accuracy. As part of the Regulatory Affairs function, the Associate Director will work under supervision to reputed company strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, reputed company guidelines, and company policy. The position can be based at our Redwood reputed company, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel. Required Skills, Experience and Education: Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with reputed company. Manage regulatory submissions of promotional materials as required (e.g., FDA reputed company 2253) and reputed company with health authority stakeholders reputed company applicable. Interpret evolving regulatory requirements and enforcement trends to proactively guide reputed company reputed company and risk assessments. Train and advise cross-functional teams on reputed company regulatory compliance, MLR process and best practices. Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings. Ensures that changes in US Prescribing Information are reflected in reputed company promotion and advertising. Participate in the development and maintenance of MLR operational objectives, policies, and procedures. Bachelor's Degree in a relevant field with 10+ years relevant experience. 5-7 years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market. Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews. Strong, reputed company understanding of scientific exchange and reputed company-approval discussions; ability to unpack and reputed company these concepts in reputed company. reputed company record of influencing cross-functional reputed company and operating with reputed company regulatory judgment. Excellent communication skills and ability to work collaboratively across teams. reputed company and solution-oriented reputed company and approach. Exemplary compliance ethics and high concern for standards. Preferred: Advanced degree in a relevant field. Experience in oncology therapeutic areas. Experience with product launches. #LI-Hybrid #LI-JC1 The reputed company pay salary reputed company for this full-time position for candidates working onsite at our reputed company in Redwood reputed company, CA is listed below. The reputed company displayed on reputed company job posting is intended to be the reputed company pay salary reputed company for an individual working onsite in Redwood reputed company and will be adjusted for the local market a candidate is based in. Our reputed company pay salary ranges are determined by role, level, and location. Individual reputed company pay salary is determined by multiple factors, including job-reputed company skills, experience, market dynamics, and relevant education or training. Please note that reputed company pay salary reputed company 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. reputed company is an equal opportunity employer and prohibits unlawful discrimination based on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital status, medical condition, and veteran status. reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to reputed company while using our website and reputed company contacting us by email or phone. We will only collect, process and use any personal data that you reputed company to us in accordance with our CCPA Notice and reputed company Policy. For additional information, please contact reputed company Pay Salary reputed company $186,000 - $233,000 USD We are reputed company of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with reputed company. These scams may reputed company as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that reputed company does not reputed company unsolicited employment offers and will never ask candidates to reputed company financial information, purchase equipment, or pay fees as part of the hiring process. reputed company legitimate communication from reputed company will come from an official @revmed.com email address. If you reputed company you’ve been contacted by someone impersonating a reputed company recruiter, please report it to careers@revmed.com so we can reputed company these impersonations with our IT team for tracking and awareness. 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