Regulatory Analyst 1

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

📋 Description

• Prepares, submits, and ensures the proper upkeep of regulatory documentation for clinical trials from the initiation phase through to completion.

• Facilitates the preparation of necessary regulatory documents for both initial and subsequent study submissions.

• Offers regulatory support for multiple clinical trials from the initiation stage through to study closure.

• Generates and revises critical regulatory documents, including the appropriate editing of consent forms in accordance with required institutional language and/or study adjustments.

• Participates in site visits conducted by sponsors or Contract Research Organizations (CROs) regarding matters related to regulatory documents.

• Ensures adherence to general and study-specific regulatory processes in line with SOPs, FDA, NIH, and other relevant regulations.

⛳️ Requirements

• Bachelor's degree in a relevant field.

• At least 2 years of experience in Regulatory Affairs within the clinical research industry, or a comparable combination of education and relevant work experience, including significant experience in regulatory affairs.

• Ability to cultivate effective interpersonal relationships.

• Proficient in both oral and written communication.

• Skilled in data collection, organization, and analysis.

• Proficiency in computer software applications (e.g., Microsoft Office).

• Capable of establishing and maintaining effective working relationships with a diverse array of internal and external cross-functional colleagues, managers, and clients.

• Familiarity with the processes involved in clinical trials.

• Awareness of relevant federal, state, and local regulations and guidelines.

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Tuition remission.

• Competitive salaries.