Manager, Regulatory Affairs: 2020-99
Mirati Therapeutics, Inc. (NASDAQ: MRTX) is a publicly traded San Diego based, clinical stage biotechnology company dedicated to advancing novel oncology therapies that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer.
Mirati Therapeutics is seeking a highly motivated and collaborative Manager to join the Regulatory Affairs group at Mirati. The successful candidate will support multiple programs for Regulatory and collaborate cross-functionally with the various Mirati departments.
This position has primary responsibility for coordination, tracking and assembly of regulatory 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 primary job functions include, but are not limited to the following:
- 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/BLAs and amendments or supplements.
- Assist regulatory management and project teams in the implementation of regulatory plans and timely delivery of regulatory documentation.
- Project manage regulatory submissions by developing, maintaining, and communicating timelines and strategy. Ability present complex regulatory information, strategy and timelines to cross-functional groups in clear and concise manner.
- 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 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.
- Review clinical site documentation to authorize investigational drug product release.
- Follow general instructions to complete projects while independently planning daily work to complete time sensitive assignments.
- Review, write and present guidelines and SOPs as needed to support high quality submissions and assure adherence to regulatory requirements.
- Support internal audits related to pre-approval or other health authority inspections
- Other duties, as needed
- A minimum of a bachelor’s degree is required, with at least 5+ years’ experience in the pharmaceutical industry experience.
- The Manager, Regulatory Affairs will ideally have a 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.
- Previous experience with Veeva Vault RIM and Veeva QualityDocs is a strong plus
- Previous experience with the implementation of electronic management systems and 21CFR11 are a strong plus.
- Established working knowledge of Good Manufacturing Practices and other applicable regulations (US and international).
- Ability to read, analyze, and interpret regulatory literature and documents. Ability to translate regulations and guidelines into terms that others can understand
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- 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, Adobe, and other applications.
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.
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Job posted: 2020-06-03