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.
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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.
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