Director, Regulatory Affairs
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 2239985
Job Description Summary
The Director, Regulatory Affairs will contribute to the formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as the regulatory contact for US/Global health authorities as required. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing documents for Health Authority meetings, as well as responses to requests. This individual will provide regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and future commercial products.
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
- Provide regulatory leadership and guidance to project teams.
- Develop response strategies and submissions to regulators.
- Develop briefing packages for meetings with FDA and other global health authorities.
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial).
- Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
- Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality - in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities.
- Provide critical review of all documentation supporting regulatory applications.
- Identify and assess regulatory risks for assigned projects or programs.
- Prepare and deliver effective presentations for external and internal audiences.
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
- Participate and contribute in Health Authority meetings as required.
What is Required
- Bachelor of Science in a scientific discipline, advanced degree highly preferred.
- Prior pharmaceutical industry experience and a minimum of 8 years in Regulatory Affairs.
- Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
- Previous small molecule drug and NDA-level experience are a strong plus.
- Established working knowledge of regulatory guidelines and regulations (US and international).
- Regulatory experience supporting both development projects and commercial products.
- Strong knowledge of eCTD elements and structure and regulatory writing skills.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
- Strong communication skills both written and oral.
- Ability to multi-task and shift priorities rapidly to meet tight deadlines.
- Professional demeanor and an excellent written and verbal communicator.
- Detail oriented and well organized.
- Good and thoughtful listener.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Proficient in Microsoft Office suite and applications.
About Mirati Therapeutics, Inc.
Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, MRTX1719, an investigational PRMT5 inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
Mirati has been named a Top Workplace by the San Diego Union-Tribune. Our passionate team are deeply motivated to participate in work that is both important and unique.
Our belief is that transforming the lives of those with cancer is more than a job -- it's the chance to be part of something game-changing.
Urgency, open-mindedness, accountability and collaboration ground our work and behavior. These shared values are central to who we are, what we do and how we do it.
Our culture is one where we challenge norms, have high-risk tolerance, and celebrate an entrepreneurial and courageous attitude full of grit and determination to make a difference. We strive to create a sense of belonging and inclusion - one in which we laugh and have fun as we drive change together.
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard 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 information, 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.