Senior IND/IDE Regulatory Affairs Specialist

Saratoga Medical Center; United States; À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Saratoga Medical Center is seeking a Remote Senior IND/IDE Regulatory Affairs Specialist to lead IND/IDE submissions and regulatory strategy for investigator-sponsored studies. The role requires strong collaboration with cross-functional teams and regulatory authorities.

The successful candidate will bring 7+ years in regulatory affairs, including at least 5 years supporting FDA IND/IDE submissions, GCP training, and familiarity with HIPAA and ICH guidelines. Remote US work is available.

Qualifications

• Bachelor's degree in a scientific or related field required.
• Advanced degree or RAC certification preferred.

Responsabilités

• Prepare and review IND/IDE applications, amendments, information amendments and annual reports.
• Prepare IND safety reports and other expedited safety submissions.
• Support FDA meetings, including pre-IND interactions, and manage regulatory correspondence.
• Maintain regulatory files, essential documents and submission trackers.
• Demonstrate knowledge of FDA regulations and guidance for investigator-sponsored studies.
• Experience with gene therapy or advanced therapeutic products is advantageous.
• Support NIH or FDA-regulated clinical research programs for 5+ years.
• Understand ICH E6, 21 CFR Parts 11, 50, 54, 56, 312, 812, 45 CFR Part 46, and HIPAA.

Connaissances

Regulatory affairs

IND/IDE submissions

FDA meetings support

GCP training

NIH/FDA-regulatedClinical research

HIPAA knowledge

CITI training

Formation

Bachelor's degree in science

Advanced degree or RAC certification

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior IND/IDE Regulatory Affairs Specialist

Remote, US

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.