Regulatory Strategist IND & NDA

Contract Regulatory Consultant – IND Submission (Oncology) Location: Remote (U.S. -based) Contract Duration: ~9 months Our client, a specialized oncology-focused CRO , is seeking an experienced Regulatory Affairs Consultant to support a critical IND submission for a novel oncology program. This is a fully remote U.S. -based contract role, expected to run for approximately 9 months , with the possibility of extension. The Role As a senior regulatory consultant, you will: • Lead and coordinate regulatory strategy and submission activities for the IND package. • Draft, review, and QC key regulatory documents (Modules 2 and 3, meeting requests/responses, briefing packages). • Partner closely with CMC, clinical, and nonclinical stakeholders to ensure alignment and readiness for submission. • Advise on FDA expectations, ICH guidelines, and oncology-specific regulatory considerations. • Support FDA interactions, including preparation for pre-IND and IND-related meetings. Requirements • Advanced degree in life sciences (Ph.D., Pharm. D., or related field) preferred. • 7+ years of U.S. regulatory affairs experience , with direct involvement in IND submissions . • Strong background in oncology drug development . • Familiarity with eCTD requirements and FDA/ICH guidance. • Excellent communication skills; comfortable working independently in a remote consulting capacity. Why This Assignment? • Opportunity to lead a high-profile oncology IND submission. • Flexibility of remote consulting work with a clear project scope. • Engagement with a CRO recognized for its depth of expertise in oncology development. If you are an experienced regulatory consultant with a proven track record in IND submissions and oncology, we’d love to hear from you. #J-18808-Ljbffr Apply tot his job