Regulatory Officer in San Juan at Sapphire HR Innovations - PR

Shape the future of clinical research while making a difference in patients' lives.

Join a fast-growing clinical research organization dedicated to advancing innovative therapies and improving healthcare outcomes. Our team partners with leading pharmaceutical sponsors to bring cutting-edge clinical trials to Puerto Rico, creating opportunities that impact both science and the community.

If you're passionate about regulatory compliance, clinical research, and working in a highly collaborative environment, we'd love to meet you.

What You'll Do

As our Regulatory Officer, you'll play a critical role in ensuring regulatory excellence across multiple clinical research studies by:

✔ Managing regulatory documentation and essential study files

✔ Coordinating submissions, amendments, renewals, and regulatory correspondence

✔ Serving as the primary liaison with Institutional Review Boards (IRBs)

✔ Supporting sponsor communications and regulatory inspections

✔ Reporting protocol deviations and Serious Adverse Events (SAEs)

✔ Maintaining compliance with Good Clinical Practice (GCP), FDA regulations, and study requirements

✔ Supporting study start-up activities and ongoing regulatory operations

✔ Collaborating closely with investigators, study coordinators, and clinic leadership to ensure regulatory readiness throughout the entire study lifecycle.

We're Looking For Someone Who Has

✔ Bachelor’s degree in science or a related field (or equivalent experience)

✔ Experience in Clinical Research and Regulatory Affairs is highly preferred

✔ Strong knowledge of Good Clinical Practice (GCP) and clinical research regulations

✔ Excellent organizational skills with exceptional attention to detail

✔ Strong analytical and problem-solving abilities

✔ Ability to manage multiple priorities while meeting strict deadlines

✔ Professional communication skills in both English and Spanish

✔ A proactive mindset with a commitment to continuous improvement and quality.

Why You'll Love This Opportunity

⭐ Work alongside experienced clinical research professionals.

⭐ Be part of studies that contribute to advancing medicine.

⭐ Join a collaborative and mission-driven team.

⭐ Grow your career in one of Puerto Rico's expanding clinical research environments.

⭐ Make a meaningful impact on patients, science, and healthcare innovation.

Ready to Make an Impact?

If you're looking for a career where regulatory excellence meets innovation and purpose, we encourage you to apply today.

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.