Remote Senior IND/IDE Regulatory Affairs Lead

Saratoga Medical Center; United States; Remoto; USD 120.000 - 180.000; Tempo integral

Resumo da vaga

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.

Qualificações

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

Responsabilidades

• 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.

Conhecimentos

Regulatory affairs

IND/IDE submissions

FDA meetings support

GCP training

NIH/FDA-regulatedClinical research

HIPAA knowledge

CITI training

Formação

Bachelor's degree in science

Advanced degree or RAC certification

Descrição da vaga

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.