Senior IND/IDE Regulatory Affairs Specialist

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 13%

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Saratoga Ascend

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1985

🏥 Healthcare

🎯 Recruiter

🏛️ Government

Healthcare • Recruitment • Government

Saratoga Ascend is a federal- and state-focused healthcare workforce and solutions firm that connects cleared, credentialed healthcare professionals with government, military, and civilian healthcare facilities across the U. S. The company provides clinical and non-clinical staffing, clinical lab and scientific staffing, call center services, federal healthcare consulting, IT solutions, program and administrative support, and SLED (state, local, education) services. With a stated four-decade legacy, nationwide coverage, rapid-fill capabilities, strict credentialing/compliance processes, and operation under federal contract vehicles, Saratoga Ascend positions itself as a government-focused healthcare staffing and program management partner.

📋 Description

• 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

• 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

• Competitive rate • Benefit options • Equal opportunity employment practices

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