Job Description Summary Mirati is looking for a talented Senior Manager / Associate Director, Regulatory Affairs to join our growing team and provide 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) and assists GRLs with strategies and submissions as appropriate. The Senior Manager / Associate Director, Regulatory Affairs will be responsible for maintaining and updating archival copies of health authority submissions (e.g. IND, BLA, and MAA). The Senior Manager / Associate Director, Regulatory Affairs will ideally have a working knowledge of regulatory requirements
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