Senior IND/IDE Regulatory Affairs Specialist

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 is hiring a Remote, Senior IND/IDE Regulatory Affairs Specialist.

• Package includes competitive rate and benefit options.

Education

Bachelor's degree in a scientific or related field required; advanced degree or RAC certification preferred.

Experience

Minimum of 7 years of regulatory affairs experience, including at least 5 years supporting FDA IND and/or IDE submissions.

Qualifications

• Preparation and review of IND/IDE applications, protocol amendments, information amendments and annual reports
• Preparation of IND safety reports and other expedited safety submissions
• Experience supporting FDA meetings, including pre-IND and other formal interactions, and managing regulatory correspondence
• Review and maintenance of 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 (e.g., CITI or equivalent)
• Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials

Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.