Regulatory CMC Manager
Department: 400 - Technical Operations / CMC : Cheng Chen/Elise Bradley/Cletus Nunes/Phil Roberts
Employment Type: Full Time
Reference Number: 1580352
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
The Manager of Regulatory Chemistry, Manufacturing and Controls (CMC) will report either directly to the Director or Vice President of Regulatory CMC. This position has primary responsibility for coordination, tracking and assembly of regulatory CMC documents for review and submission to health authorities (FDA, EMA and other regulatory agencies as needed). The Regulatory Manager will assist the program Global Regulatory Leads with strategy and submissions as appropriate. The ideal candidate will have a strong CMC technical background and experience with preparing CMC regulatory submissions. In addition, excellent verbal and written communications skills are required.
- Under the direction of a senior Regulatory staff member, participate in the preparation of regulatory dossiers (e.g. IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards.
- Support CMC teams and provide direction on the interpretation of global CMC regulations.
- Assist regulatory management and project teams in the implementation of regulatory plans and timely delivery of regulatory documentation.
- Research and provide analysis of current US and international regulations and guidance.
- Project manage regulatory submissions by developing, maintaining, and communicating timelines and strategy.
- Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed.
- Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols and investigator brochures.
- Communicates critical issues to Management
What is Required:
- A minimum of a Bachelor of Science in chemistry or pharmaceutical science with a minimum of 5 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required.
- An MS, Ph.D., or Pharm. D. degree preferred.
- Knowledge of European and FDA regulations.
- Ability present complex regulatory information, strategy and timelines to cross-functional groups in clear and concise manner.
- Strong attention to detail with high-level verbal and written communication skills is required.
- Experience directly writing submission documents that support clinical trials preferred.
- Ability to work as part of and lead multiple teams, and to present and defend CMC management-approved regulatory strategy and opinion to project teams is required.
- Exhibits leadership skill and ability.
- Excellent problem-solving, analytical thinking skills is required.
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic informations, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.