Senior IND/IDE Regulatory Affairs Specialist

Saratoga Ascend

. Prepare and review IND/IDE applications, protocol amendments, information amendments, and annual reports .

Posted 11/5/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory affairs, particularly in preparing and reviewing IND/IDE applications and safety reports, while ensuring compliance with FDA regulations and Good Clinical Practice. Proven ability to manage regulatory correspondence and collaborate effectively within multidisciplinary teams.

Highest-signal resume keywords

Regulatory Affairs ExperienceIND/IDE Application PreparationFDA Submission SupportKnowledge of FDA RegulationsGood Clinical Practice (ICH E6)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

IND/IDE Application PreparationIND Safety Report PreparationRegulatory File ReviewSubmission Tracker MaintenanceProtocol Amendment ReviewInformation Amendment ReviewAnnual Report PreparationRegulatory Correspondence ManagementFDA Meeting SupportClinical Research Program Support

Soft Skills

CollaborationCommunicationTeamwork

Certifications & Qualifications

RAC CertificationCITI Training

Industry Keywords

FDA RegulationsGood Clinical Practice21 CFR Parts 11, 50, 54, 56, 312, 81245 CFR Part 46HIPAAGene TherapyAdvanced Therapeutic ProductsNIH-Regulated Clinical Research

About the role

Key responsibilities & impact

Prepare and review IND/IDE applications, protocol amendments, information amendments, and annual reports
Prepare IND safety reports and other expedited safety submissions
Support FDA meetings, including pre-IND and other formal interactions
Manage regulatory correspondence
Review and maintain regulatory files and essential documents
Maintain submission trackers
Work in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff, and program officials

Requirements

What you’ll need

Bachelor's degree in a scientific or related field required
Advanced degree or RAC certification preferred
Minimum of 7 years of regulatory affairs experience
At least 5 years supporting FDA IND and/or IDE submissions
Experience preparing and reviewing IND/IDE applications, protocol amendments, information amendments, and annual reports
Experience preparing IND safety reports and other expedited safety submissions
Experience supporting FDA meetings, including pre-IND and other formal interactions, and managing regulatory correspondence
Experience reviewing and maintaining regulatory files, essential documents, and submission trackers
Strong knowledge of FDA regulations and guidance applicable to investigator-sponsored studies
Experience with gene therapy or other advanced therapeutic products is advantageous
Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 as applicable, 45 CFR Part 46, and HIPAA
Current human subjects protections and GCP training, such as CITI or equivalent
Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff, and program officials

Benefits

Comp & perks

Competitive rate
Benefit options
Equal opportunity employment practices