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.