Sr. Director, Clinical Regulatory Affairs
📋 Role Overview & Responsibilities
Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory strategies to obtain and maintain clinical trial applicationsOversees the creation and submission of all regulatory filings Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agenciesDemonstrated track records of successful regulatory meetings, IND or BLA submissions and approvalsExperience in Oncology and Immuno-oncology is preferred but not requiredArranges for and leads meetings with global health authorities as neededProvides training and mentorship to regulatory staff and other junior staff at the company
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This position is located in Waltham, MA with potential relocation and sponsorship assistance depending on candidate qualifications.
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