Senior IND/IDE Regulatory Affairs Lead — Remote

Saratoga Ascend; Oregon; Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive rate & benefits

Job summary

Saratoga Medical Center, Inc. is seeking a Remote, Senior IND/IDE Regulatory Affairs Specialist to lead regulatory submissions and interactions with FDA.

The role requires deep hands-on experience with IND/IDE programs and governance of regulatory documentation in a multidisciplinary setting. The ideal candidate has a strong background in FDA regulations, GCP, HIPAA, and NIH/FDA clinical research programs, with remote work experience and the ability to collaborate with government investigators

Qualifications

• Preparation and review of IND/IDE applications, amendments and annual reports.
• Preparation of IND safety reports and expedited safety submissions.
• Experience supporting FDA meetings, including pre-IND interactions and regulatory correspondence.
• Review and maintenance of regulatory files and submission trackers.
• Strong knowledge of FDA regulations and guidance for investigator-sponsored studies.
• Gene therapy or advanced therapeutic products experience is advantageous.
• Five+ years in NIH/FDA-regulated clinical research programs.
• Work in accordance with ICH E6, 21 CFR Parts 11, 50, 54, 56, 312, 812, 45 CFR Part 46 and HIPAA.

Responsibilities

• Prepare and review IND/IDE applications, amendments and annual reports.
• Prepare IND safety reports and expedited safety submissions.
• Support FDA meetings and manage regulatory correspondence.
• Maintain regulatory files and submission trackers.
• Ensure compliance with FDA regulations for investigator-sponsored studies.
• Collaborate with multidisciplinary teams including Government staff and investigators.

Skills

IND/IDE submissions

FDA meetings

Regulatory knowledge

GCP training

HIPAA knowledge

Cross-functional teamwork

NIH/FDA clinical research

Regulatory correspondence

Education

Bachelor's degree in science

Advanced degree or RAC

Job description

Saratoga Medical Center, Inc. is seeking a Remote, Senior IND/IDE Regulatory Affairs Specialist to lead regulatory submissions and interactions with FDA.

The role requires deep hands-on experience with IND/IDE programs and governance of regulatory documentation in a multidisciplinary setting. The ideal candidate has a strong background in FDA regulations, GCP, HIPAA, and NIH/FDA clinical research programs, with remote work experience and the ability to collaborate with government investigators