Manager, Regulatory Operations
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1806149
Job Description Summary
Reporting directly to the Senior Director of Regulatory Operations, the Manager, Regulatory Operations will be responsible for supporting the operational aspects of global regulatory submissions, ensuring that submissions are high quality and submitted on-time. This role is also responsible for supporting the archiving and tracking of regulatory submissions and health authority correspondence.
The ideal candidate must be proficient in regulatory agency submissions requirements, the use of electronic document management and regulatory publishing and submission tools.
- Support compilation, publishing, and management of regulatory submissions.
- Perform reviews of regulatory submissions to ensure quality.
- Support regulatory filing goals through collaboration with cross-functional teams, ensuring accuracy of regulatory submission content.
- Manage eCTD service provider, as needed.
- Create and maintain Regulatory Operations timelines across all products for original and lifecycle submissions.
- Perform other duties as required.
What is Required
- Minimum 5 years' experience working in a biotechnology or pharmaceutical Regulatory Operations environment.
- Proven track record of generating eCTD compliant submissions. Strong understanding of eCTD publishing/validation concepts; experience with GlobalSubmit PUBLISH, Veeva Vault, and DXC Toolbox is a plus.
- Training and experience leading to expert use of programs used in regulatory submission compilation.
- Advanced proficiency using MS Word, MS SharePoint, Adobe Acrobat Professional, as well as experience with MS Excel, MS PowerPoint, and MS Project.
- Knowledge of global regulatory health authority requirements for submissions, especially those relating to FDA submission requirements including document formatting and XML validation.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
- 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
Mirati Therapeutics is a late-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, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
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. Together, we own Mirati's success.
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.