Regulatory Officer in San Juan at Sapphire HR Innovations - PR

We are seeking a highly qualified and meticulous candidate for the position of Regulatory Affairs Manager. Our center is dedicated to excellence in clinical research, ensuring an efficient, high-quality, and compliant environment for all our trials.

If you thrive in a fast-paced environment, possess excellent organizational skills, and have a passion for delivering exceptional patient service, this is the opportunity for you to make a meaningful impact in healthcare delivery.

Position Details:

• Type of Position: Regular – Exempt.

• Setting: Fast-paced and highly regulated clinical research environment.

• Location: San Juan

• $17 -$18 (D) Hourly

Job Summary: The Regulatory Officer is responsible for supporting the center’s transition to the digital Regulatory system, mastering the platform, uploading general site documents, and providing system support to team members. This role coordinates closely with the Site Operations Manager, Site Operations Liaison, and Principal Investigators to ensure timely submissions, report deviations to the IRB, and maintain strict compliance throughout the trial lifecycle.

Key Duties and Responsibilities:

• Create, maintain, and organize study-specific regulatory documents, product registration files, and technical dossiers.

• Manage the complete regulatory process for all clinical studies conducted at the center.

• Report serious adverse events (SAEs) and protocol deviations to the IRB in a timely and accurate manner.

• Interface with study sponsors regarding regulatory documentation, participate in system validation, and assist during monitor visits or audits.

• Follow up with Principal Investigators to ensure timely completion and signature of Case Report Forms (CRFs).

• Conduct internal compliance audits to assess adherence to established clinical protocols and identify areas for improvement.

• Serve as the primary point of contact with IRBs, maintaining all official correspondence and reports.

• Update, maintain, and assist in developing standard operating procedures (SOPs).

• Ensure site personnel comply with Good Clinical Practice (GCP) guidelines, professional licenses, and protocol-specific training.

• Inform the Clinic Director systematically about regulatory activities, outcomes, and trial statuses.

Skills and Abilities:

• Excellent analytical skills and the ability to accurately interpret complex documents and regulatory policies.

• Strong time management and organizational skills with a proven ability to meet strict deadlines.

• Solid understanding of medical terminology and pharmacology.

• Proficiency in both Spanish and English languages (written and verbal).

• Basic understanding of administration and management principles.

Education and Experience:

• Bachelor’s degree in Science or a related field.

• Equivalent professional experience in clinical research regulation is highly valued.

Physical & Working Conditions:

• Requires prolonged periods of sitting at a desk, working on a computer, and occasional standing in a lab environment. Must be able to lift up to 15 pounds at times.

• The role requires high discretion, adaptability, and may involve occasional travel or remote coordination with external stakeholders.

Sapphire HR Innovations is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other protected characteristic under applicable law.