Supervisor, Reg Affairs

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Supervisor, Regulatory Affairs based in the United States.

The Supervisor, Regulatory Affairs will oversee critical regulatory operations across pharmaceutical and medical device product portfolios, ensuring compliance with applicable FDA requirements and industry standards. You will lead a team of regulatory and quality specialists responsible for product labeling approvals, drug listings, medical device identification submissions, and regulatory documentation.

Working closely with Quality Assurance, Packaging Operations, Commercial Product Development, Legal, and external partners, you will resolve complex compliance challenges and strengthen operational processes. You will play a key role in maintaining accurate regulatory databases, managing quality investigations, and supporting risk assessments that protect product integrity and patient safety.

In addition, you will refine standard operating procedures, promote consistent quality practices, and ensure regulatory submissions are accurate and timely. This nationwide remote opportunity is ideal for an experienced regulatory professional who combines technical expertise with people leadership and a commitment to continuous improvement in a highly regulated healthcare environment.