Senior Manager, Regulatory Affairs and Operations
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1740951
Job Description Summary
Reporting directly to the Director of Regulatory Operations, the Senior Manager of Regulatory Operations will be responsible for the technical preparation, submission, and archiving of all global regulatory submissions; ensuring that submissions are of high quality and submitted on-time. In addition to management of traditional regulatory operations functions, the SM/AD must also serve as the Business Administrator for Veeva Vault RIM.
The ideal candidate must have expert proficiency in regulatory agency submissions requirements, eCTD publishing, electronic document management, and be experienced in implementing and managing Regulatory Operations-specific software.
- Manage the compilation, publishing, and submission of electronic, hybrid, and paper
- Manage the quality of regulatory submissions to ensure compliance with applicable technical
- Manage regulatory filing goals through collaboration with cross-functional teams; ensuring accuracy of regulatory submission
- Manage publishing service providers and contractors, as needed.
- Manage Regulatory Operations timelines across all products for original and lifecycle
- Perform other duties as required.
What is Required
- BS and minimum 7-10 years' experience working in a biotechnology or pharmaceutical Regulatory Operations environment.
- Proven track record of generating eCTD compliant Expert understanding of eCTD publishing/validation concepts; experience with Global Submit PUBLISH, Veeva Vault RIM, Starting Point and DXC Toolbox is a plus.
- Training and experience leading to expert use of programs used in regulatory submission
- Advanced proficiency using MS Word, MS SharePoint, Adobe Acrobat Professional, as well as experience with MS Excel, MS PowerPoint, and MS
- Expert knowledge of global regulatory health authority requirements for submissions, especially those relating to FDA submission requirements including document formatting and XML
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
- Strong communication skills both written and
- Ability to multi-task and shift priorities rapidly to meet tight
- Professional demeanor and an excellent written and verbal
- Detail oriented and well organized.
- Good and thoughtful
- Enthusiastic, self-motivated and keen to improve processes and overcome
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 KRAS G12C 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 KRAS G12D 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.