Regulatory Strategist IND

1 day ago

Scottsdale, United States BioTalent Full time

Contract Regulatory Consultant - IND Submission (Oncology)Location: Remote (U.S.-based)Contract Duration: ~9 monthsOur 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 RoleAs 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. RequirementsAdvanced 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.

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