Senior IND/IDE Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare and evaluate IND/IDE applications, as well as protocol amendments, information amendments, and annual reports.

• Create IND safety reports and other expedited safety submissions.

• Assist in FDA meetings, including pre-IND consultations and other formal interactions.

• Oversee regulatory correspondence.

• Review and uphold regulatory files and essential documentation.

• Maintain trackers for submissions.

• Collaborate within a multidisciplinary team environment with Government clinical investigators, regulatory personnel, and program officials.

⛳️ Requirements

• A Bachelor's degree in a scientific or related discipline is required.

• An advanced degree or RAC certification is preferred.

• A minimum of 7 years of experience in regulatory affairs is necessary.

• At least 5 years of experience supporting FDA IND and/or IDE submissions.

• Proven experience in preparing and reviewing IND/IDE applications, protocol amendments, information amendments, and annual reports.

• Experience in preparing IND safety reports and other expedited safety submissions.

• Background in supporting FDA meetings, including pre-IND consultations and managing regulatory correspondence.

• Proficient in reviewing and maintaining regulatory files, essential documents, and submission trackers.

• Strong understanding of FDA regulations and guidance relevant to investigator-sponsored studies.

• Experience with gene therapy or other advanced therapeutic products is a plus.

• Five or more years of direct experience in supporting NIH or FDA-regulated clinical research programs.

• Familiarity with Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 as applicable, 45 CFR Part 46, and HIPAA.

• Current training in human subjects protections and GCP, such as CITI or an equivalent program.

• Experience working within a multidisciplinary team setting alongside Government clinical investigators, regulatory staff, and program officials.

🏝️ Benefits

• Competitive compensation rate.

• Various benefit options available.

• Commitment to equal opportunity employment practices.