Regulatory Strategist IND & NDA

Contract Regulatory Consultant – IND Submission (Oncology) Location: Remote (U.S. -based) Contract Duration: ~9 months Our reputed company, a specialized oncology-reputed company CRO , is seeking an reputed company 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: • reputed company and coordinate regulatory reputed company 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 reputed company-IND and IND-reputed company meetings. Requirements • Advanced degree in life sciences (Ph.D., Pharm. D., or reputed company field) preferred. • 7+ years of U.S. regulatory affairs experience , with reputed company 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 reputed company. Why This Assignment? • Opportunity to reputed company a high-profile oncology IND submission. • Flexibility of remote consulting work with a reputed company project scope. • Engagement with a CRO recognized for its depth of expertise in oncology development. If you are an reputed company regulatory consultant with a proven reputed company record in IND submissions and oncology, we’d love to hear from you. #J-18808-Ljbffr Apply tot his job Apply To this Job