Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 2131882
Job Description Summary
The Regulatory Associate will report directly to the Associate Director, Regulatory Affairs. The Regulatory Associate provides key support to the Regulatory Affairs department. This position has primary responsibility for coordination and assembly of regulatory documents for review and submission to health authorities (primarily the FDA, other regulatory agencies as needed). The Regulatory Associate will ideally have some working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs. In addition, excellent verbal and written communications skills are required.
- Under the direction of a senior Regulatory staff member, prepare, compile review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs and amendments or supplements.
- Assist regulatory management and project teams in the implementation of regulatory plans and timely delivery of regulatory documentation.
- Develop, maintain, and communicate timelines for regulatory submissions.
- Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
- Coordinate with other departments (i.e. Clinical, Nonclinical, CMC) and Regulatory Operations to gather and assemble information necessary for submissions to health authorities in accordance with regulations and guidelines.
- Maintain databases of regulatory information, submissions and correspondence.
- Follow general instructions to complete projects while independently planning daily work to complete time sensitive assignments.
- Review documents required as part of the Regulatory Site Documentation for the shipment of drug product to the clinical sites.
- Review ClinicalTrials.Gov Postings and serve as a system administrator.
- Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration.
What is Required:
- A minimum of a BS in life sciences with at least 1 year of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries (an equivalent combination of education and experience in pharmaceutical drug development, biotech or related field may be considered).
- Understanding of the drug development process and knowledge of global guidance and regulations.
- Has successfully supported health authority submissions or similar deliverables and critical projects while maintaining agreed timelines.
- Previous experience with IND filings or maintenance and/or experience with eCTD formatted submissions desirable
- Excellent oral and written communication skills.
- Time management skills are essential.
- Demonstrated ability to work effectively with cross-functional teams e.g. research, clinical, and CMC teams.
- Ability to implement regulatory plans and strategies and proactively identify risks.
- Ability to work on multiple tasks to meet company objectives.
- Strong attention to detail.
- Knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
- Excellent Computer Skills MS Word, Excel, Power Point, and document management software/system.
- Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus
- Previous experience with maintaining in house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (eg, Veeva) is a plus
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.