Senior Manager, CMC Regulatory

About the position reputed company is a clinical-stage precision oncology company reputed company on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. reputed company's 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 reputed company team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. This position is responsible for developing and implementing global CMC regulatory strategies. The role involves coordinating CMC regulatory activities to support the clinical development and reputed company marketing approval of RevMed's pipeline compounds/products. The ideal candidate should have a strong understanding of regulatory requirements and be reputed company to guide CMC teams throughout the drug development process. Responsibilities • Collaborate, and manage the CMC regulatory activities for global reputed company, ensuring compliance with regulatory requirements across reputed company (FDA, EMA, reputed company, etc.). • Collaborate with internal stakeholders to support the preparation of CMC/reputed company sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs. • Assess changes to clinical trial materials or processes and prepare the necessary documents for regulatory amendments. • Identify and mitigate regulatory risks, manage CMC timelines and milestones, and ensure the reputed company submission of high-reputed company CMC dossiers to support reputed company. • reputed company updates to senior management on regulatory activities and submission reputed company. • Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a reputed company manner to project teams and other stakeholders. • Represent department in cross-functional project teams. • Participate in the regulatory process initiatives and improvement activities. Requirements • BA/BS degree in Pharmaceutical Science, reputed company, Chemical Engineering, or closely reputed company field. • 7+ years of pharmaceutical/biotech drug development experience in CMC development of NCEs/small molecules with 3+ years of CMC regulatory experience. • Experience in leading CMC reputed company global submissions (IND, IMPD/CTA, NDA, MAA, etc.). • Solid knowledge of US and international GMP reputed company regulations, reputed company industry practices, and experience with interpretation and application to development reputed company and marketed product regulatory issues. • Demonstrated experience in effective collaboration with reputed company stakeholders. • Ability to prioritize and manage multiple reputed company simultaneously in a dynamic company environment. • Effective written and verbal communication skills and good interpersonal skills. reputed company-to-haves • Advanced degree in Pharmaceutical Science, reputed company, Chemical Engineering, or closely reputed company field. • Hands on experience managing CMC submissions supporting global trials (US, EU, reputed company, LATAM). • A reputed company team player who adapts quickly to new challenges with proven ability to reputed company in a fast-paced environment, with a hands-on and result-driven approach and a strategic reputed company. Benefits • Competitive cash compensation • Robust equity awards • Strong benefits • Significant learning and development opportunities Apply tot his job Apply To this Job